Status:
TERMINATED
Glutamine PET Imaging Colorectal Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
RAS Wild Type
Stage IV Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 i...
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-t...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2025
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03275974
Start Date
April 27 2021
End Date
December 23 2025
Last Update
January 2 2026
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030