Glutamine PET Imaging Colorectal Cancer

  • End date
    May 31, 2025
  • participants needed
  • sponsor
    M.D. Anderson Cancer Center
Updated on 10 August 2022


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.



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).


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.

Condition RAS Wild Type, Stage IV Colorectal Cancer, Stage IVA Colorectal Cancer, Stage IVB Colorectal Cancer
Treatment positron emission tomography, Blood draw, Carbon C 11 Glutamine, Fluorine F 18 L-glutamate Derivative BAY94-9392
Clinical Study IdentifierNCT03275974
SponsorM.D. Anderson Cancer Center
Last Modified on10 August 2022


Yes No Not Sure

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
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