Clinical trial NCT03275974: Glutamine PET Imaging Colorectal Cancer
Official title: Glutamine PET Imaging of Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: RAS Wild Type
Stage IV Colorectal Cancer
Stage IVA Colorectal Cancer
Stage IVB Colorectal Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pet imaging
timeFrame: Baseline prior to treatment with anti-EGFR mAb
measure: Pharmacokinetic rate constants for 11C-Glutamine and 18F-FSPG
timeFrame: Baseline prior to treatment with anti-EGFR mAb
measure: 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)
Secondary outcomes:
measure: Gene expression
timeFrame: Prior to treatment with anti-EGFR mAb
measure: Progression free survival
timeFrame: every 8 weeks while on treatment (after every two (2) cycles of anti-EGFR mAb therapy (each cycle is 4 weeks)); Up to 4 years after treatment
measure: Overall survival
timeFrame: Up to 4 years after treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lesley Flynt
role: PRINCIPAL_INVESTIGATOR
References: