Status:
TERMINATED
Multi-Tracer Positron Emission Tomography in Patients With Solid Tumors
Lead Sponsor:
University of Utah
Conditions:
Malignant Neoplasm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This clinical trial studies multi-tracer positron emission tomography in patients with solid tumors. Diagnostic procedures, such as multi-tracer positron emission tomography, may help measure a patien...
Detailed Description
PRIMARY OBJECTIVES: I. Provide a reliable and validated cadre of positron emission tomography (PET) imaging derived biomarkers that yield a better understanding of: 1) early clinical benefit from var...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 2 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2016
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01243333
Start Date
February 2 2011
End Date
April 8 2016
Last Update
April 17 2024
Active Locations (1)
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1
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112