Multi-Tracer Positron Emission Tomography in Patients With Solid Tumors

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