{
"info": {
"nct_id": "NCT06057831",
"official_title": "18FDG-PET/MRI Imaging in Predicting Pathological Response to Total Neo-adjuvant Therapy in Rectal Cancer",
"inclusion_criteria": "1. Patients with histologically proven adenocarcinoma of the rectum.\n2. Clinical stage 2-3 rectal adenocarcinoma, cT3/4N0/M0 or Tx N1-2/M0, within 16 cm from anal verge (lesion below the sacral promontory).\n3. Patients deemed suitable to undergo TNT followed by surgical resection.\n4. Male or female ≥ 18 years of age.\n5. ECOG/Zubrod status 0-2.\n6. Able and willing to follow instructions and comply with the protocol.\n7. Provide written informed consent prior to participation in the study.\n8. Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening if there is concern about pregnancy. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal.\n9. If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, concerned about pregnancy are not eligible for the study.\n10. Females must not be breastfeeding (during treatment and at least 6 months from the last dose).\n11. Male patients should agree that not donate sperm during the study (during treatment and at least 6 months from the last dose).\n12. Patients of childbearing/reproductive potential should use highly effective birth control methods if indicated, as defined by the investigator, up to the period of finishing adjuvant chemotherapy. A highly effective method of birth control is defined as those that result in low failure rate (i.e., less than 1% per year) when used consistently and correctly.\n\nNote: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Patient receiving short course radiotherapy alone for rectal cancer.\n2. Patient receiving standard TNT.\n3. Patients with metastatic disease.\n4. Prior pelvic radiotherapy or chemotherapy.\n5. Patients in whom MRI is contra-indicated as per prevailing institutional guidelines (e.g. pacemakers, aneurysm clips, cochlear implant, implanted cardiac defibrillator).\n6. Prior or concurrent malignancy (except non-melanomatous skin cancer) unless disease-free for at least 5 years.\n7. Inability to lay in supine position for approximately one hour.\n8. Nursing or pregnant females.\n9. Age <18 years.\n10. Previous and concurrent, experimental, chemotherapy, or radiotherapy treatment for primary rectal carcinoma.\n11. Patients with malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal (GI) function.\n12. Patients with a known history of documented upper GI bleeding or upper GI ulcerative disease.\n13. Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction.\n14. Known current alcohol abuse.\n15. Patients with symptomatic inflammatory bowel disease.\n16. Patients with uncontrolled hypothyroidism.\n17. Patients with chronic liver disease.\n18. Patients known to be suffering from infection with HIV, Tuberculosis, Hepatitis C or Hepatitis B.\n19. Any contra-indications for intravenous contrast.\n20. History of anaphylactic reaction to medications or drug allergy.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Patients with histologically proven adenocarcinoma of the rectum.",
"criterions": [
{
"exact_snippets": "histologically proven adenocarcinoma of the rectum",
"criterion": "adenocarcinoma of the rectum",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": "histologically proven"
}
]
}
]
},
{
"line": "2. Clinical stage 2-3 rectal adenocarcinoma, cT3/4N0/M0 or Tx N1-2/M0, within 16 cm from anal verge (lesion below the sacral promontory).",
"criterions": [
{
"exact_snippets": "Clinical stage 2-3 rectal adenocarcinoma",
"criterion": "rectal adenocarcinoma",
"requirements": [
{
"requirement_type": "clinical stage",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
]
},
{
"exact_snippets": "cT3/4N0/M0 or Tx N1-2/M0",
"criterion": "tumor classification",
"requirements": [
{
"requirement_type": "TNM classification",
"expected_value": [
"cT3/4N0/M0",
"Tx N1-2/M0"
]
}
]
},
{
"exact_snippets": "within 16 cm from anal verge",
"criterion": "distance from anal verge",
"requirements": [
{
"requirement_type": "distance",
"expected_value": {
"operator": "<=",
"value": 16,
"unit": "cm"
}
}
]
},
{
"exact_snippets": "lesion below the sacral promontory",
"criterion": "lesion location",
"requirements": [
{
"requirement_type": "location",
"expected_value": "below the sacral promontory"
}
]
}
]
},
{
"line": "3. Patients deemed suitable to undergo TNT followed by surgical resection.",
"criterions": [
{
"exact_snippets": "Patients deemed suitable to undergo TNT",
"criterion": "suitability for TNT",
"requirements": [
{
"requirement_type": "suitability",
"expected_value": true
}
]
},
{
"exact_snippets": "suitable to undergo ... surgical resection",
"criterion": "suitability for surgical resection",
"requirements": [
{
"requirement_type": "suitability",
"expected_value": true
}
]
}
]
},
{
"line": "4. Male or female ≥ 18 years of age.",
"criterions": [
{
"exact_snippets": "Male or female",
"criterion": "gender",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "≥ 18 years of age",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "5. ECOG/Zubrod status 0-2.",
"criterions": [
{
"exact_snippets": "ECOG/Zubrod status 0-2",
"criterion": "ECOG/Zubrod status",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "6. Able and willing to follow instructions and comply with the protocol.",
"criterions": [
{
"exact_snippets": "Able and willing to follow instructions",
"criterion": "ability and willingness to follow instructions",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "comply with the protocol",
"criterion": "compliance with the protocol",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "7. Provide written informed consent prior to participation in the study.",
"criterions": [
{
"exact_snippets": "Provide written informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "8. Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening if there is concern about pregnancy. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal.",
"criterions": [
{
"exact_snippets": "Women of childbearing potential (WOCBP)",
"criterion": "women of childbearing potential",
"requirements": [
{
"requirement_type": "definition",
"expected_value": "any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal"
}
]
},
{
"exact_snippets": "must have a negative serum (or urine) pregnancy test",
"criterion": "pregnancy test",
"requirements": [
{
"requirement_type": "result",
"expected_value": "negative"
}
]
},
{
"exact_snippets": "at the time of screening",
"criterion": "timing of pregnancy test",
"requirements": [
{
"requirement_type": "timing",
"expected_value": "at the time of screening"
}
]
},
{
"exact_snippets": "if there is concern about pregnancy",
"criterion": "concern about pregnancy",
"requirements": [
{
"requirement_type": "condition",
"expected_value": "if there is concern about pregnancy"
}
]
}
]
},
{
"line": "9. If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, concerned about pregnancy are not eligible for the study.",
"criterions": [
{
"exact_snippets": "female of child-bearing potential",
"criterion": "gender and reproductive potential",
"requirements": [
{
"requirement_type": "gender",
"expected_value": "female"
},
{
"requirement_type": "reproductive potential",
"expected_value": "child-bearing"
}
]
},
{
"exact_snippets": "outside of the window of 10 days since the first day of the last menstrual period",
"criterion": "menstrual cycle timing",
"requirements": [
{
"requirement_type": "timing",
"expected_value": {
"operator": ">",
"value": 10,
"unit": "days since the first day of the last menstrual period"
}
}
]
},
{
"exact_snippets": "concerned about pregnancy",
"criterion": "pregnancy concern",
"requirements": [
{
"requirement_type": "concern",
"expected_value": true
}
]
}
]
},
{
"line": "10. Females must not be breastfeeding (during treatment and at least 6 months from the last dose).",
"criterions": [
{
"exact_snippets": "Females must not be breastfeeding",
"criterion": "breastfeeding",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "at least 6 months from the last dose",
"criterion": "time since last dose",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
]
}
]
},
{
"line": "11. Male patients should agree that not donate sperm during the study (during treatment and at least 6 months from the last dose).",
"criterions": [
{
"exact_snippets": "Male patients should agree that not donate sperm during the study (during treatment and at least 6 months from the last dose).",
"criterion": "sperm donation",
"requirements": [
{
"requirement_type": "agreement",
"expected_value": false
}
]
}
]
},
{
"line": "12. Patients of childbearing/reproductive potential should use highly effective birth control methods if indicated, as defined by the investigator, up to the period of finishing adjuvant chemotherapy. A highly effective method of birth control is defined as those that result in low failure rate (i.e., less than 1% per year) when used consistently and correctly.",
"criterions": [
{
"exact_snippets": "Patients of childbearing/reproductive potential",
"criterion": "childbearing/reproductive potential",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "should use highly effective birth control methods",
"criterion": "use of highly effective birth control methods",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": true
}
]
},
{
"exact_snippets": "A highly effective method of birth control is defined as those that result in low failure rate (i.e., less than 1% per year)",
"criterion": "birth control method effectiveness",
"requirements": [
{
"requirement_type": "failure rate",
"expected_value": {
"operator": "<",
"value": 1,
"unit": "% per year"
}
}
]
}
]
},
{
"line": "Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.",
"criterions": [
{
"exact_snippets": "abstinence is acceptable",
"criterion": "abstinence",
"requirements": [
{
"requirement_type": "acceptability",
"expected_value": true
}
]
},
{
"exact_snippets": "preferred contraception for the patient",
"criterion": "preferred contraception",
"requirements": [
{
"requirement_type": "establishment",
"expected_value": true
}
]
},
{
"exact_snippets": "accepted as a local standard",
"criterion": "local standard acceptance",
"requirements": [
{
"requirement_type": "acceptability",
"expected_value": true
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "1. Patient receiving short course radiotherapy alone for rectal cancer.",
"criterions": [
{
"exact_snippets": "Patient receiving short course radiotherapy alone for rectal cancer.",
"criterion": "treatment type",
"requirements": [
{
"requirement_type": "specific treatment",
"expected_value": "short course radiotherapy alone"
}
]
},
{
"exact_snippets": "Patient receiving short course radiotherapy alone for rectal cancer.",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "specific cancer",
"expected_value": "rectal cancer"
}
]
}
]
},
{
"line": "2. Patient receiving standard TNT.",
"criterions": [
{
"exact_snippets": "Patient receiving standard TNT.",
"criterion": "standard TNT",
"requirements": [
{
"requirement_type": "receiving",
"expected_value": true
}
]
}
]
},
{
"line": "3. Patients with metastatic disease.",
"criterions": [
{
"exact_snippets": "Patients with metastatic disease",
"criterion": "metastatic disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "4. Prior pelvic radiotherapy or chemotherapy.",
"criterions": [
{
"exact_snippets": "Prior pelvic radiotherapy",
"criterion": "pelvic radiotherapy",
"requirements": [
{
"requirement_type": "prior treatment",
"expected_value": true
}
]
},
{
"exact_snippets": "Prior ... chemotherapy",
"criterion": "chemotherapy",
"requirements": [
{
"requirement_type": "prior treatment",
"expected_value": true
}
]
}
]
},
{
"line": "5. Patients in whom MRI is contra-indicated as per prevailing institutional guidelines (e.g. pacemakers, aneurysm clips, cochlear implant, implanted cardiac defibrillator).",
"criterions": [
{
"exact_snippets": "MRI is contra-indicated",
"criterion": "MRI contraindication",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "pacemakers",
"criterion": "pacemaker",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "aneurysm clips",
"criterion": "aneurysm clip",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "cochlear implant",
"criterion": "cochlear implant",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "implanted cardiac defibrillator",
"criterion": "implanted cardiac defibrillator",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "6. Prior or concurrent malignancy (except non-melanomatous skin cancer) unless disease-free for at least 5 years.",
"criterions": [
{
"exact_snippets": "Prior or concurrent malignancy",
"criterion": "malignancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "disease-free for at least 5 years",
"criterion": "disease-free period",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 5,
"unit": "years"
}
}
]
}
]
},
{
"line": "7. Inability to lay in supine position for approximately one hour.",
"criterions": [
{
"exact_snippets": "Inability to lay in supine position for approximately one hour.",
"criterion": "ability to lay in supine position",
"requirements": [
{
"requirement_type": "duration",
"expected_value": "approximately one hour"
}
]
}
]
},
{
"line": "8. Nursing or pregnant females.",
"criterions": [
{
"exact_snippets": "Nursing ... females",
"criterion": "nursing status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "pregnant females",
"criterion": "pregnancy status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "9. Age <18 years.",
"criterions": [
{
"exact_snippets": "Age <18 years.",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "10. Previous and concurrent, experimental, chemotherapy, or radiotherapy treatment for primary rectal carcinoma.",
"criterions": [
{
"exact_snippets": "Previous and concurrent, experimental, chemotherapy, or radiotherapy treatment for primary rectal carcinoma.",
"criterion": "previous treatment for primary rectal carcinoma",
"requirements": [
{
"requirement_type": "treatment type",
"expected_value": [
"experimental",
"chemotherapy",
"radiotherapy"
]
}
]
},
{
"exact_snippets": "Previous and concurrent, experimental, chemotherapy, or radiotherapy treatment for primary rectal carcinoma.",
"criterion": "concurrent treatment for primary rectal carcinoma",
"requirements": [
{
"requirement_type": "treatment type",
"expected_value": [
"experimental",
"chemotherapy",
"radiotherapy"
]
}
]
}
]
},
{
"line": "11. Patients with malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal (GI) function.",
"criterions": [
{
"exact_snippets": "malabsorption syndrome",
"criterion": "malabsorption syndrome",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "ulcerative colitis",
"criterion": "ulcerative colitis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "resection of the stomach or small bowel",
"criterion": "resection of the stomach or small bowel",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "other disease significantly affecting gastrointestinal (GI) function",
"criterion": "disease affecting gastrointestinal function",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "significant"
}
]
}
]
},
{
"line": "12. Patients with a known history of documented upper GI bleeding or upper GI ulcerative disease.",
"criterions": [
{
"exact_snippets": "known history of documented upper GI bleeding",
"criterion": "upper GI bleeding",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "known history of documented ... upper GI ulcerative disease",
"criterion": "upper GI ulcerative disease",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "13. Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction.",
"criterions": [
{
"exact_snippets": "untreated and/or uncontrolled cardiovascular conditions",
"criterion": "cardiovascular conditions",
"requirements": [
{
"requirement_type": "treatment status",
"expected_value": "untreated"
},
{
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
]
},
{
"exact_snippets": "symptomatic cardiac dysfunction",
"criterion": "cardiac dysfunction",
"requirements": [
{
"requirement_type": "symptoms",
"expected_value": true
}
]
}
]
},
{
"line": "14. Known current alcohol abuse.",
"criterions": [
{
"exact_snippets": "Known current alcohol abuse",
"criterion": "alcohol abuse",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
},
{
"requirement_type": "timeframe",
"expected_value": "current"
}
]
}
]
},
{
"line": "15. Patients with symptomatic inflammatory bowel disease.",
"criterions": [
{
"exact_snippets": "symptomatic inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirements": [
{
"requirement_type": "symptom presence",
"expected_value": true
}
]
}
]
},
{
"line": "16. Patients with uncontrolled hypothyroidism.",
"criterions": [
{
"exact_snippets": "uncontrolled hypothyroidism",
"criterion": "hypothyroidism",
"requirements": [
{
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
]
}
]
},
{
"line": "17. Patients with chronic liver disease.",
"criterions": [
{
"exact_snippets": "Patients with chronic liver disease",
"criterion": "chronic liver disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "18. Patients known to be suffering from infection with HIV, Tuberculosis, Hepatitis C or Hepatitis B.",
"criterions": [
{
"exact_snippets": "infection with HIV",
"criterion": "HIV infection",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "infection with ... Tuberculosis",
"criterion": "Tuberculosis infection",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "infection with ... Hepatitis C",
"criterion": "Hepatitis C infection",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "infection with ... Hepatitis B",
"criterion": "Hepatitis B infection",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "19. Any contra-indications for intravenous contrast.",
"criterions": [
{
"exact_snippets": "contra-indications for intravenous contrast",
"criterion": "intravenous contrast",
"requirements": [
{
"requirement_type": "contra-indications",
"expected_value": false
}
]
}
]
},
{
"line": "20. History of anaphylactic reaction to medications or drug allergy.",
"criterions": [
{
"exact_snippets": "History of anaphylactic reaction to medications",
"criterion": "anaphylactic reaction to medications",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "drug allergy",
"criterion": "drug allergy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}