NCT03275974

Glutamine PET Imaging Colorectal Cancer

Glutamine PET Imaging of Colorectal Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• RAS Wild Type
• Stage IV Colorectal Cancer
• Stage IVA Colorectal Cancer
• Stage IVB Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Carbon C 11 Glutamine	Given by IV
BIOLOGICAL	Fluorine F 18 L-glutamate Derivative BAY94-9392	Given by IV
PROCEDURE	Positron Emission Tomography	Undergo PET scan
PROCEDURE	Blood Draw	Undergo venous blood draws

Timeline

• Start date: 2021-04-27
• Primary completion: 2025-12-23
• Completion: 2025-12-23
• First posted: 2017-09-08
• Last updated: 2026-01-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study