Glutamine PET Imaging Colorectal Cancer

M.D. Anderson Cancer Center

Status and phase: Terminated; Phase 1

Conditions: RAS Wild Type; Stage IV Colorectal Cancer; Stage IVA Colorectal Cancer; Stage IVB Colorectal Cancer

Treatments: Procedure: Blood Draw; Biological: Fluorine F 18 L-glutamate Derivative BAY94-9392; Procedure: Positron Emission Tomography; Biological: Carbon C 11 Glutamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03275974

NCI-2017-01543 (Other Identifier)

2020-1083

Details and patient eligibility

About

The clinical trial studies how well 11C-glutamine and 18F-FSPG positron emission tomography (PET) imaging works in detecting tumors in patients with metastatic colorectal cancer compared to standard imaging methods such as magnetic resonance imaging (MRI) or computed tomography (CT) scanning.

Full description

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 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;
• Archived tissue from the CRC primary tumor in sufficient amounts to allow RNA-seq gene analysis; specimen from metastatic sites are not required but highly preferred;
• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

6 participants in 1 patient group

Treatment

Experimental group

Description:

Patients receive carbon C 11 Glutamine (11C-glutamine) 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 (18F-FSPG) 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.

Treatment:

Procedure: Positron Emission Tomography

Biological: Carbon C 11 Glutamine

Biological: Fluorine F 18 L-glutamate Derivative BAY94-9392

Procedure: Blood Draw