Glutamine PET Imaging Colorectal Cancer

PRIMARY OBJECTIVES:

I. To establish and validate a 11C-glutamine (11C-Gln) and fluorine F 18 L-glutamate
derivative BAY94-9392 (18F-FSPG) PET image guided gene signature to predict response to
EGFR-targeted therapy in patients with advanced wild-type RAS colorectal cancer (CRC).

OUTLINE:

Patients will undergo a CT-guided core biopsy after completion of all previous therapies and
within 2 weeks of PET imaging scans. Patients receive 11C-glutamine intravenously (IV) and
undergo PET imaging over 120 minutes. Beginning 2 hours to 7 days after 11C-glutamine PET,
patients receive fluorine F 18 L-glutamate derivative BAY94-9392 IV and also undergo PET
imaging over 120 minutes. During each of the 11C-Glutamine and 18F-FSPG PET/CT scans, venous
blood draws will be performed.

Inclusion Criteria:

- ≥18 years of age;

- Pathologically or cytologically confirmed diagnosis of metastatic (Stage IV) RAS
wildtype CRC;

- Eligible for anti-EGFR monoclonal antibody (mAb) therapy as standard-of-care (SOC),
either as a single agent or in combination with approved SOC therapies or
investigational agents as part of IRB-approved clinical trials;

- Must be willing to undergo a pre-treatment biopsy;

- Documented results from (or scheduled to undergo) CT or MRI of the chest, abdomen and
pelvis as a standard-of-care procedure within 28 days of baseline investigational
11C-Gln PET/CT and 18F-FSPG PET/CT;

- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;

- At least one lesion >2 cm in diameter and thus will be measurable according to PET
Response Criteria in Solid Tumors (PERCIST) v1.0 to avoid PET partial volume effects;

- Ability to provide written informed consent in accordance with institutional policies.

Exclusion Criteria:

- Any other current or previous malignancy within the past 5 years

- Previous EGFR-directed therapy

- Body weight ≥ 400 pounds or body habitus or disability that will not permit the
imaging protocol to be performed

- Pregnant or lactating females