Glutamine PET Imaging Colorectal Cancer

Stage IV Colorectal Cancer Clinical Trial

Official title:

Glutamine PET Imaging of Colorectal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03275974
• Other study ID #: 2020-1083
• Secondary ID: NCI-2017-01543
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 27, 2021
• Est. completion date: November 30, 2024

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• Carbon C 11 Glutamine
Given by IV
• Fluorine F 18 L-glutamate Derivative BAY94-9392
Given by IV

Procedure:
• Positron Emission Tomography
Undergo PET scan
• Blood Draw
Undergo venous blood draws

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pet imaging	Assessed in terms of Standardized Uptake Values (SUVs)	Baseline prior to treatment with anti-EGFR mAb
Primary	Pharmacokinetic rate constants for 11C-Glutamine and 18F-FSPG	The pharmacokinetic rate constants for 11C-Glutamine and 18F-FSPG will be determined using compartmental modeling of PET imaging data. Venous samples will be collected over the course of both 11C-Glutamine and 18F-FSPG scans for use in modeling.	Baseline prior to treatment with anti-EGFR mAb
Primary	Change in tumor size	Change in tumor size will be derived from standard-of-care computed tomography (CT) or magnetic resonance imaging (MRI). The tumor size will be reported as either the long-axis diameter or as tumor volume.	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	Gene expression	Gene expression will be determined using RNA-Seq of archived primary (and if available, metastatic) tissues.	Prior to treatment with anti-EGFR mAb
Secondary	Progression free survival	Progression-free survival is defined as the time from start of therapy to disease progression by RECIST criteria or death for any reason.	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
Secondary	Overall survival	Overall survival is defined as the time from start of treatment to death for any reason.	Up to 4 years after treatment

External Links

•   MD Anderson Cancer Center