Random or fasting blood glucose =< the upper normal limits for age; if the initial blood glucose is a random sample that is outside of the normal limits, then follow-up fasting blood glucose can be obtained and must be =< the upper normal limits for age
Glucose < 200 mg/dl
Uncontrolled diabetes (if non-fasting blood sugar > 200 mg/dl, perform a fasting blood sugar which must be =< 200 mg/dl)
Fasting serum glucose =< 130 mg/dL
Within less than or equal to 14 days prior to registration: Fasting serum glucose =< 130 mg/dL
Patients must have a normal blood sugar level for age to participate; if an initial random draw (ie. non-fasting) blood glucose value is out of range, it is acceptable to repeat this test as a fasting draw
Patients must have a normal blood sugar level for age; if an initial random draw (i.e. non-fasting) blood glucose value is out of range, it is acceptable to repeat this test as a fasting draw
Fasting serum glucose (=< 130 mg/dL)
Random or fasting blood glucose within the upper normal limits for age; if the initial blood glucose is a random sample that is outside of the normal limits, then a follow-up fasting (no food or drink other than water for 8 hours) blood glucose can be obtained and must be within the upper limits for age
Uncontrolled diabetes as defined by fasting serum glucose > 1.5x ULN
Uncontrolled diabetes as defined by fasting glucose >1.5 times the ULN. Note: these participants can be included after initiation or adjustment of glucose-lowering medication.
Normal blood glucose for age
Glucose, serum < 200 mg/dL
Diagnosis of diabetes mellitus defined as\r\n* Fasting blood glucose > 126 mg/dl or\r\n* Random blood glucose > 200 mg/dl\r\n* Hemoglobin A1C > 6.5%
Patients with uncontrolled diabetes or fasting blood glucose > 200 mg/dL may enroll but will not be evaluable for PET imaging
Fasting serum glucose (=< 130 mg/dL)
Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications; patients with diabetes will preferably be scheduled for PET/CT imaging in the morning, and instructions for fasting and use of medications will be provided in consultation with the patients’ primary physicians
Diabetes must be controlled prior to PET-CT scanning (blood glucose < 200 mg/dL)
Fasting glucose within normal limits
Obtained =< 14 days prior to registration: Fasting serum glucose =< 1.5 x ULN
Fasting serum glucose =< 130 mg/dL.
Fasting blood glucose (FBG) < 130 mg/dL
Fasting or random blood glucose within the upper limits of normal for age
If random blood glucose is above upper limits for age, a fasting blood glucose can be obtained and must be within normal limits for age
Blood glucose <1.5 ULN within 30 days of enrollment to study
Fasting serum glucose (=< 130 mg/dL)
Fasting serum glucose =< 130 mg/dL
Fasting glucose =< 160 mg/dL (CTCAE grade 1 baseline)
History of Type 1 or 2 diabetes mellitus requiring regular medication (other than oral hypoglycemic agents) or fasting glucose ? 160 mg/dL at the Pre-Study visit
Fasting serum glucose (=<130 mg/dL)
Metabolic: fasting serum glucose (=< 130 mg/dL)
Fasting serum glucose (=< 130 mg/dL)
Fasting serum glucose =< 130 mg/dL
History of Type 1 or 2 diabetes mellitus requiring regular medication (other than oral hypoglycemic agents including metformin) or fasting glucose ? 160 mg/dL
Glucose >= 80 mg/dL
Fasting serum glucose =< 130 mg/dL
Within 30 days of first vaccination: Blood glucose < 1.5 ULN
Subjects unable to maintain blood glucose less than 200 mg/dl may not be suitable for the PET/MRI substudy
Glucose < 200 mg/dL
Uncontrolled diabetes mellitus, or subjects with either of the following:\r\n* Fasting blood glucose (FBG defined as fasting for at least 8 hours) >= 200 mg/dL (7.0 mmol/L), or\r\n* Glycosylated hemoglobin measurement (HbA1c) >= 8%
Within 4 weeks of preregistration: Blood glucose =< 126 mg/dL fasting or =< 140 mg/dL nonfasting
ELIGIBILITY CRITERIA FOR REGISTRATION: blood glucose =< 126 mg/dL fasting or =< 140 mg/dL nonfasting (within one week of registration if patient postop, otherwise within two weeks of registration)
EXCLUSION CRITERIA FOR REGISTRATION: subjects with known diabetes, fasting glucose over 126 mg/dL or random glucose over 140 mg/dL and those taking metformin, sulfonylureas, thiazolidinediones or insulin for any reason; either fasting OR random glucose may be used to determine eligibility
Fasting blood sugar =< 160 mg/dL; patient may be on diabetic medication to achieve glucose control\r\n* Documented fasting blood sugars =< 160 mg/dL\r\n* Diabetic subjects who have recently had their glycemic control regimens adjusted and have documented fasting blood glucose concentrations =< 160 mg/dL may be considered regardless of hemoglobin A1C (HgbA1c) value, if per investigator discretion the subject is considered to have adequate glycemic function
TREATMENT: Patients who have poorly controlled diabetes (defined as fasting blood glucose of > 160 mg/dL (Common Terminology Criteria for Adverse Events [CTCAE] grade >= 2) and glycated hemoglobin (HgA1c) > 8% are ineligible to receive treatment with everolimus on study; patients with fasting blood glucose > 160 mg/dL may be eligible if the HgA1c < 8%, per PI discretion
Patients with uncontrolled diabetes mellitus (fasting blood glucose controlled by medication, =< 200 mg/dL allowed)
Uncontrolled diabetes (if random blood sugar > 200 mg/dL, perform fasting blood sugar to ensure < 200 mg/dL)
Fasting glucose < 125 mg/dL obtained within 28 days prior to sub-study registration
Fasting glucose < 125 mg/dL obtained within 28 days prior to Step 2 re-registration
Fasting glucose =< 120 mg/dL
Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN
Fasting blood glucose =< 125 mg/dL within 14 days prior to registration
Fasting glucose < 160 mg/dL
Baseline fasting blood glucose must be =< 140 mg/dL and hemoglobin A1c less than 7.5% (with or without the use of anti-diabetic medications)
Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications
Normal fasting glucose
Diabetes or elevated fasting blood sugar either by history or by hemoglobin A1c (HgbA1c) greater than 6.5% or fasting serum glucose greater than 100 mg/dL on screening labs; if fasting serum glucose is greater than 100mg/dL on screening labs, this test will be repeated to confirm the results
Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN
Fasting plasma glucose < 140 mg/dl (may be on antiglycemic agents other than insulin); fasting glucose measurement must be obtained at least 8 hours after the most recent caloric intake
Fasting glucose value ? 160 mg/dL (CTCAE Grade 1 baseline)
Patients must not have uncontrolled diabetes mellitus (defined by fasting serum glucose > 1.5 x ULN) obtained within 28 days prior to registration; optimal glucose control must be achieved before registration and monitored during protocol treatment
Uncontrolled diabetes, as evidenced by fasting serum glucose level >200 mg/dL
Glucose =< 2 x ULN
Fasting (greater than or equal to [>=] 8 hours) glucose less than or equal to (<=) 160 milligrams per deciliter (mg/dL)
Random or fasting blood glucose within the upper normal limits for age; if the initial blood glucose is a random sample that is outside of the normal limits, then a follow-up fasting blood glucose can be obtained and must be within the upper normal limits for age
Fasting serum glucose =< 130 mg/dL
Fasting glucose < 140 mg/dL
Type I diabetes mellitus (DM), type II DM patients requiring insulin for chronic blood glucose control, and any patients with a fasting blood glucose > 140 mg/dL (7.8 mmol/L) at screening will be excluded
Fasting glucose < 120 mg/dL
Patients with a fasting blood glucose >= 120 mg/dL (6.7 mmol/L); patients with diabetes mellitus are eligible if they require oral agents only and have a fasting blood glucose =< 120 mg/dL; patients with a history of diabetes mellitus who require daily long-acting or mealtime insulin are not eligible; patients who have previously required treatment for hyperglycemia due to steroids or other medications are eligible as long as they have not required insulin or any other oral agent within 2 months prior to study enrollment
Fasting glucose < 250 mg/dL; patients with diabetes are allowed to participate, provided that their blood glucose is < 250 mg/dL upon enrollment
Fasting blood glucose within institutional normal limits
Additional criteria for Group B participants who will receive upfront window therapy (does not apply to participants who opt out of window therapy):\r\n* Cytochrome P450 3A4 (CYP3A4) active agents: must not be taking any of the following potent CYP3A4 inducers or inhibitors within 1 week prior to study entry: azole antifungals (such as fluconazole, voriconazole, itraconazole, ketoconazole), rifampin, phenytoin, phenobarbital, carbamazepine, grapefruit juice and St. John’s wort\r\n* Must have measurable disease\r\n* Must not have received emergent radiation therapy\r\n* Serum triglyceride level =< 300 mg/dL and serum cholesterol =< 300 mg/dL\r\n* Random or fasting glucose within the upper limits of normal for age; if random glucose is elevated, fasting glucose must be within normal range
Uncontrolled diabetes, as defined by fasting serum glucose > 1.5 times ULN*
Fasting plasma glucose < 140 mg/dl (may be on antiglycemic agents other than insulin); fasting glucose measurement must be obtained at least 8 hours after the most recent caloric intake
Uncontrolled diabetes (as defined by fasting glucose >= 140 mg/dL) and/or insulin-dependent diabetes; fasting glucose measurement must be obtained at least 8 hours after the most recent caloric intake; patients currently requiring the use of antiglycemic agents (other than insulin) may be enrolled if fasting glucose < 140 mg/dL
Have a random glucose of =< 65 or >= 200
Type I or II diabetes mellitus with HbA1c > 8.5% or fasting plasma glucose > 160 mg/dL at screening.
Patients with diabetes, OR fasting blood glucose level >= 126 mg/dl\r\n* NOTE: patients with drug induced diabetes are eligible if the offending drug has been stopped and the patient’s fasting blood glucose level has recovered to < 126 mg/dl
Uncontrolled diabetes mellitus as defined by a fasting blood glucose >2 ULN.
f. Poorly controlled diabetes (fasting blood glucose > 180 mg/dL)
Uncontrolled diabetes as defined by fasting glucose >1.5 times the ULN. Note: these participants can be included after initiation or adjustment of glucose-lowering medication
Fasting serum glucose =< 150 mg/dl (fasting is defined as at least 8 hours without oral intake)
Patient does not have uncontrolled diabetes mellitus (fasting blood glucose > 200 mg/dL)
Fasting serum glucose =< 130 mg/dL
Uncontrolled diabetes mellitus (fasting plasma glucose > 130 mg/dL)
Fasting glucose less than or equal to (</=) 125 milligrams per deciliter (mg/dL)
Fasting serum glucose < 1.5 x ULN obtained =< 7 days prior to registration
Poorly controlled diabetes as defined by a fasting serum glucose > 2.0 x ULN.
Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN
Fasting glucose =< 150 mg/dL
The participant has fasting serum glucose less than or equal to 125 mg/dL, and hemoglobin A1C less than or equal to 6%.
Current diagnosis of type I or II diabetes mellitus or fasting blood glucose level >125 mg/dL at screening, or HbA1c 7%
Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN
The participant has fasting serum glucose < 160 milligram/deciliter (mg/dL) and hemoglobin A1c (HgbA1c)? 7. If baseline nonfasting glucose is < 160 mg/dL, fasting glucose measurement is not required
Fasting serum glucose (=< 130 mg/dL)
Uncontrolled diabetes as defined by fasting glucose >1.5 times the ULN. Note: In case this threshold is exceeded, these participants can only be included after initiation or adjustment of glucose-lowering medication.
Free from history of chronic disease including uncontrolled diabetes (fasting blood glucose > 125 mg/dL), hypertension (blood pressure > 130/90 mmHg) or thyroid disease (< 0.4 or > 4.0 mIU/L); this will be determined by review of medical records and/or physician clearance
Diabetes mellitus or glucose intolerance, defined as a fasting glucose > 125 mg/dL
NON-CANCER PATIENT GROUP: Metabolically unhealthy: abdominal obesity + (at least one of the following: resting blood pressure above 140 systolic or 90 diastolic or anti-hypertensive medication use or fasting glucose above 100 mg/dL or type II diabetes mellitus)
Patients who require frequent (several times a day) monitoring of their blood glucose or patients who have recently been hospitalized for glucose control
Uncontrolled hyperglycemia as defined by any blood glucose of > 300 mg/dl in the past two weeks
Random glucose < 160 mg/dL or fasting glucose < 126 mg/dL (other values require workup to rule out undiagnosed diabetes that may require treatment)
Currently on medications for diabetes treatment (patients with hyperglycemia [random glucose < 160 mg/dL or fasting glucose < 126 mg/dl] but who are not on any drug treatment are eligible)
Patients with fasting capillary blood glucose of > 140 on the day of surgery
Fasting blood glucose =< 120 mg/dL
Fasting blood glucose =< 115 mg/dL
It is recommended glucose be drawn fasting >= 8 hrs; glucose < 126 (diabetics 40–75 years of age are not eligible), within 30 days prior to enrollment\r\n* If glucose is >= 126 the glucose should be repeated fasting to determine eligibility
Fasting serum glucose =< 130 MG/DL
Not frankly diabetic, as measured by a fasting blood glucose =< 126 mg/dL
Type I or II diabetes; documented fasting plasma glucose > 125 mg/dL, current exposure to antidiabetic medications, including insulin
Glucose within 2 x ULN
Blood glucose > 200
Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL)
Uncontrolled diabetes or blood glucose > 175 mg/dl on the day of the FDG-PET scan
Recent or current history of diabetes mellitus, defined as:1) diabetes therapy within 6 months of enrollment, or 2) fasting blood glucose at “pre-admit” (screening) visit >= 126 mg/dL
Patients with diabetes mellitus, with uncontrolled fasting blood glucose level (above 200 mg/dl)
Severe diabetes (fasting blood glucose > 200 mg/dl)
Uncontrolled diabetes mellitus (fasting glucose greater than 200 mg/dL)
Any patient with diabetes mellitus or steroid-induced hyperglycemia (fasting glucose > 150)
Uncontrolled diabetes mellitus (fasting glucose > 200 mg/dL)
Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL)
Patient with poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL; optimally participants will have glucose < 150 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications
Poorly controlled diabetes mellitus (fasting blood glucose > 200)
Blood glucose >= 200 mg/dL at the time of PET-MRI (or if diabetic, uncontrolled blood glucose); at the discretion of the principal investigator (PI) and the authorized user and with their approval prior to FDG injection, patients with blood glucose >= 200 mg/dL may participate in the study
Patient must not be an uncontrolled diabetic with a glucose of >= 200 mg/dl at the time of PET imaging
Uncontrolled hyperglycemia (defined as inability to achieve a glucose of < 250 mg/dL at time of FDG injection)
Blood glucose of < 80 mg/dL or > 150 mg/dL
Uncontrolled diabetes with a fasting glucose >= 200 mg/dl at the time of PET/MRI imaging
Serum glucose > 200 mg/dL
Fasting glucose > 200 mg/dL or