[c09aa8]: / clusters / 9knumclustersv2 / clust_2964.txt

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Alkaline phosphatase =< . x upper limit of reference range (or =< x upper limit of reference range if considered to be related to liver or bone metastases by the principal investigator [PI])
STUDY TREATMENT: Serum aminotransferase value less than . times the upper limit of the normal range
Hemoglobin within % of upper and lower limit of normal range of test (gender based)
Platelet within % of upper and lower limit of normal range of test
DONOR: Hemoglobin within % of upper and lower limit of normal range of test (gender based for hemoglobin)
DONOR: WBC within % of upper and lower limit of normal range of test (gender based for hemoglobin)
DONOR: Platelet within % of upper and lower limit of normal range of test (gender based for hemoglobin)
DONORS: Hemoglobin within % of upper and lower limit of normal range of test (gender based for hemoglobin)
DONORS: White blood cells (WBC) within % of upper and lower limit of normal range of test (gender based for hemoglobin)
DONORS: Platelets within % of upper and lower limit of normal range of test (gender based for hemoglobin)
Serum bilirubin levels =< . times the upper limit of the normal (ULN) range for the laboratory; higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis
Does the subject have an ALT < times the upper limit of the laboratory reference range and total bilirubin < . mg/dL?
Serum bilirubin greater than . times the upper limit of reference range (ULRR).
Serum creatinine > . times upper reference range
Pre-imaging laboratory tests must be performed within days prior to the [F] FLT imaging procedure; these must be less than . times below or above the upper or lower limit range for the respective laboratory test for entry into the study (unless clinically not relevant); in those instances where a laboratory value is outside of this range, then such a patient will be ineligible for enrollment; for follow-up scanning sessions after therapy has been instituted, laboratory testing will also be required due to the use of [F] FLT; the patients have brain tumors and will have received chemoradiation; therefore, many routine laboratory tests may not be within the typical normal range; as such, a factor of . times above or below the upper or lower value for the normal range for any laboratory test will also be used to determine the acceptable range for the nd and possibly rd imaging time points (unless clinically not relevant); the baseline laboratory testing will include liver enzymes (alanine transaminase [ALT], aspartate aminotransferase [AST]), bilirubin (total), serum electrolytes, complete blood count (CBC) with platelets, prothrombin time, partial thromboplastin time, blood urea nitrogen (BUN), and creatinine; for those patients receiving coumadin or another anticoagulant the upper limit for prothrombin time or partial thromboplastin time must not exceed times the upper limit of the normal range
Pre-treatment laboratory tests for patients receiving [F]FMISO must be performed within days prior to the FMISO scan; these laboratory tests must be less than . times below or above the upper or lower limit range for the respective laboratory test for entry into the study (unless not clinically relevant); for those patients receiving Coumadin or another anticoagulant the upper limit for prothrombin time or partial thromboplastin time must not exceed times the upper limit of the normal range
Gamma-glutamyl transpeptidase (GGT) less than . times below or above the upper or lower limit range
Bilirubin (total) less than . times below or above the upper or lower limit range
Amylase less than . times below or above the upper or lower limit range
Albumin less than . times below or above the upper or lower limit range
Sodium less than . times below or above the upper or lower limit range
Potassium less than . times below or above the upper or lower limit range
Chloride less than . times below or above the upper or lower limit range
Bicarbonate (HCO) less than . times below or above the upper or lower limit range
Calcium less than . times below or above the upper or lower limit range
Phosphorus less than . times below or above the upper or lower limit range
Creatinine less than . times below or above the upper or lower limit range
Urea nitrogen less than . times below or above the upper or lower limit range
Glucose less than . times below or above the upper or lower limit range
Complete blood count (CBC) with platelets less than . times below or above the upper or lower limit range
Prothrombin time less than . times below or above the upper or lower limit range
Partial thromboplastin time less than . times below or above the upper or lower limit range
Pre-treatment laboratory tests for patients receiving [F]FLT must be performed within days prior to study entry; these must be less than . times below or above the upper or lower limit range for the respective laboratory test for entry into the study (unless clinically not relevant); in those instances where a baseline laboratory value is outside of this range, then such a patient will be ineligible for enrollment; for the follow-up scanning sessions after therapy has been instituted, laboratory testing will also be required due to the use of FLT; the patients have brain tumors and will have received various forms of therapy; therefore, many routine laboratory tests may not be within the typical normal range; as such, a factor of . times above or below the upper or lower value for the normal range for any laboratory test will also be used to determine the acceptable range for the nd and possible rd imaging time points (unless clinically not relevant); the baseline laboratory testing will include liver enzymes (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALK], lactate dehydrogenase [LDH]), bilirubin (total), serum electrolytes, complete blood count (CBC) with platelets and, prothrombin time, partial thromboplastin time, blood urea nitrogen (BUN), creatinine; previous urinalysis abnormalities will not preclude the patient from being studied; for those patients receiving Coumadin or another anticoagulant the upper limit for prothrombin time or partial thromboplastin time must not exceed times the upper limit of the normal range
Serum creatinine =< . times upper reference range
Serum glutamate pyruvate transaminase (SGPT) less than . times below or above the upper or lower limit range
Total bilirubin less than . times below or above the upper or lower limit range
Serum electrolytes less than . times below or above the upper or lower limit range
Complete blood count (CBC) with platelets less than . times below or above the upper or lower limit range
Prothrombin time less than . times below or above the upper or lower limit range; for those patients receiving Coumadin or another anticoagulant the upper limit for prothrombin time must not exceed times the upper limit of the normal range
Partial thromboplastin time less than . times below or above the upper or lower limit range; for those patients receiving Coumadin or another anticoagulant the upper limit for partial thromboplastin time must not exceed times the upper limit of the normal range
Creatinine less than . times below or above the upper or lower limit range
Pre-treatment laboratory tests for patients receiving fluorine F fluorothymidine ([F]FLT) must be performed within days prior to baseline imaging; these laboratory tests must be less than . times below or above the upper or lower limit range for the respective laboratory test for entry into the study (unless not clinically relevant); . x for prothrombin time and partial thromboplastin time; for those patients receiving Coumadin or another anticoagulant the upper limit for prothrombin time or partial thromboplastin time must not exceed times the upper limit of the normal range; the initial . x value will be critical for liver function test results which can be extremely variable, and a . x above the upper normal range is still acceptable for inclusion in this study; urinalysis abnormalities will not preclude the patient from being enrolled and studied; the baseline and subsequent laboratory testing will include liver enzymes (serum glutamic oxaloacetic transaminase [SGOT], serum glutamate pyruvate transaminase [SGPT], anaplastic lymphoma kinase [ALK]), bilirubin (total), serum electrolytes, complete blood count (CBC) with platelets prothrombin time, partial thromboplastin time, blood urea nitrogen (BUN), and creatinine
For the follow-up scanning sessions after therapy has been instituted and within days prior to the second [F]FLT study the laboratory assessments will be required due to the use of [F]FLT; these studies should also be less than . times below or above the upper or lower limit range for the respective laboratory study (unless not clinically relevant); . x for prothrombin time and partial thromboplastin time; however at the discretion of the study principal investigator (PI) the second imaging sessions can occur if laboratory values are not within the X upper limit of normal (unless not clinically relevant); for those patients receiving Coumadin or another anticoagulant the upper limit for prothrombin time or partial thromboplastin time must not exceed times the upper limit of the normal range; for the assessments at subsequent imaging time points the laboratory tests as described for baseline assessment will again be obtained
Patients must have adequate hepatic and renal function as evidenced by bilirubin . times the upper limit of the normal range (ULN) or lower, alanine aminotransferase (ALT) and asparate aminotransferase (AST) times the ULN or lower, serum creatinine . times the ULN or lower. Patients with nonclinically significant elevations of bilirubin up to . g/dL ( ?mol/L) due to known or suspected Gilbert's disease are eligible; this must be documented on the medical history page of the case report form (CRF).