Multi-Tracer Positron Emission Tomography in Patients With Solid Tumors
Multi-Tracer Positron Emission Tomography in Patients With Solid Tumors
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 patient's response to treatment.
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
 various therapeutic agents in investigational and recently approved therapies; 2) efficacy
 during novel therapeutics in investigational therapeutics and recently approved therapeutics
 at Huntsman Cancer Institute (HCI); and 3) possible predict prognosis or other long-term
 outcomes.

 II. Reveal a more detailed understanding of: (1) the in vivo biologic mechanisms of various
 therapeutic drugs in investigational therapies and recently approved therapies at HCI (2)
 information on why particular functional imaging profiles are seen in treated patients.

 III. Reveal a more detailed understanding of how the combination of molecular imaging derived
 biomarkers will be potentially useful to physicians for decision making and for explanation
 of efficacy or outcomes for patients with cancer.

 IV. Implement and evaluate a new imaging technology for multi-tracer PET imaging of these
 tracers.

 OUTLINE:

 Patients undergo PET scans with fludeoxyglucose (FDG) F 18 (18FDG), fluorine F 18
 fluorothymidine (FLT), and water (H2O) O-15 (15O) tracers at baseline and within 7 days of
 completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses.
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