Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT01243333
Eligibility Criteria:
Inclusion Criteria:
* Eligible adult patients currently meeting inclusion criteria and will be treated with an investigational or recently approved therapeutic agent at HCI; the patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; RECIST imaging must be current and have been obtained within 30 days prior to the baseline imaging session
* Patients must document their willingness to be followed for a period of time; for the purposes of imaging data analysis this will ideally be for at least 12 months after completing the investigational or recently approved therapy, however this may not always be possible; by signing informed consent, the patients are documenting their agreement to have clinical and radiographic endpoints and the results of histopathologic tissue analysis and other laboratory information entered into a research database
* All patients must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
* Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to baseline and the subsequent set of multi-tracer PET scans; the serum pregnancy test must be performed within 48 hours prior to research PET imaging; a negative test will be necessary for such patients to undergo research PET imaging
* Serum glutamic oxaloacetic transaminase (SGOT) less than 4.0 times below or above the upper or lower limit range
* Serum glutamate pyruvate transaminase (SGPT) less than 4.0 times below or above the upper or lower limit range
* Alkaline phosphatase (ALK phos) less than 4.0 times below or above the upper or lower limit range
* Lactate dehydrogenase (LDH) less than 4.0 times below or above the upper or lower limit range
* Total bilirubin less than 4.0 times below or above the upper or lower limit range
* Serum electrolytes less than 4.0 times below or above the upper or lower limit range
* Complete blood count (CBC) with platelets less than 4.0 times below or above the upper or lower limit range
* Prothrombin time less than 2.5 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 6 times the upper limit of the normal range
* Partial thromboplastin time less than 2.5 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 6 times the upper limit of the normal range
* Blood urea nitrogen (BUN) less than 4.0 times below or above the upper or lower limit range
* Creatinine less than 4.0 times below or above the upper or lower limit range
* Urinalysis less than 4.0 times below or above the upper or lower limit range; urinalysis abnormalities will not preclude the patient from being enrolled and studied
Exclusion Criteria:
* Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals; patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion
* Patients who are pregnant or lactating or who suspect they might be pregnant; serum pregnancy tests will be obtained prior to the baseline and subsequent multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile
* Adult patients who require monitored anesthesia for PET scanning
* Patients known to be human immunodeficiency virus (HIV) positive
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01243333
Study Brief:
Protocol Section:
NCT01243333