TerminatedPhase 1

Glutamine PET Imaging Colorectal Cancer

Stopped: \<75% participation

United States6 participantsStarted 2021-04-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Pet imaging

Timeframe: Baseline prior to treatment with anti-EGFR mAb

Pharmacokinetic rate constants for 11C-Glutamine and 18F-FSPG

Timeframe: Baseline prior to treatment with anti-EGFR mAb

Change in tumor size

Timeframe: Baseline prior to treatment with anti-EGFR mAb and every 8 weeks while on treatment (after every two (2) cycles of anti-EGFR mAb therapy (each cycle is 4 weeks)); through treatment completion, an average of 24 weeks (6 cycles)

Trial details

NCT IDNCT03275974

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-23

View on ClinicalTrials.gov More RAS Wild Type trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Pet imaging

Timeframe: Baseline prior to treatment with anti-EGFR mAb

Pharmacokinetic rate constants for 11C-Glutamine and 18F-FSPG

Timeframe: Baseline prior to treatment with anti-EGFR mAb

Change in tumor size