Glutamine PET Imaging Colorectal Cancer

NCT03275974 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: 2020-1083NCI-2017-01543
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

RAS Wild Type; Stage IVA Colorectal Cancer; Stage IVB Colorectal Cancer; Stage IV Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

• Pet imaging

  Assessed in terms of Standardized Uptake Values (SUVs)

  Baseline prior to treatment with anti-EGFR mAb

• 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

• 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 Outcomes (3)

• Gene expression

  Prior to treatment with anti-EGFR mAb

• Progression free survival

  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

• Overall survival

  Up to 4 years after treatment

Study Arms (1)

Treatment

EXPERIMENTAL

Patients receive carbon C 11 Glutamine (11C-glutamine) 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 (18F-FSPG) 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.

Biological: Carbon C 11 Glutamine; Biological: Fluorine F 18 L-glutamate Derivative BAY94-9392; Procedure: Positron Emission Tomography; Procedure: Blood Draw

Interventions

Carbon C 11 Glutamine BIOLOGICAL

Given by IV

Treatment

Fluorine F 18 L-glutamate Derivative BAY94-9392 BIOLOGICAL

Given by IV

Treatment

Positron Emission Tomography PROCEDURE

Undergo PET scan

Treatment

Blood Draw PROCEDURE

Undergo venous blood draws

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Magnetic Resonance Spectroscopy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Simone Krebs

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: September 8, 2017
• Study Start: April 27, 2021
• Primary Completion: December 23, 2025
• Study Completion: December 23, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-09

Locations

US (1)