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Glutamine PET Imaging for Colorectal Cancer

Phase 1

Waitlist Available

Led By Lesley Flynt

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 years of age

Pathologically or cytologically confirmed diagnosis of metastatic (Stage IV) RAS wildtype CRC

Must not have

Previous EGFR-directed therapy

Body weight ≥ 400 pounds or body habitus or disability that will not permit the imaging protocol to be performed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years after treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way of imaging tumors in patients with metastatic colorectal cancer, to see if it is more effective than the standard methods.

Who is the study for?

This trial is for adults over 18 with metastatic colorectal cancer that hasn't been treated with EGFR-directed therapy. They must have a tumor sample available, measurable disease by certain criteria, and be eligible for anti-EGFR antibody therapy. It's not for those who are pregnant, lactating, or have had another cancer in the past 5 years.

What is being tested?

The study tests how well two PET imaging agents (11C-glutamine and 18F-FSPG) detect tumors compared to standard MRI or CT scans in patients with metastatic colorectal cancer. The goal is to see if these new agents offer clearer images of the tumors.

What are the potential side effects?

Potential side effects from the PET imaging process may include discomfort at the injection site, allergic reactions to tracers, and exposure to radiation which carries a risk of cancer though it's very low.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My colorectal cancer is stage IV and RAS wildtype.

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I am eligible for anti-EGFR therapy as part of my standard cancer treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received treatment targeting EGFR before.

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My weight is over 400 pounds or my body shape or disability prevents me from undergoing certain scans.

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I have not had any other cancer in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in tumor size

Pet imaging

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

Secondary study objectives

Gene expression

Overall survival

Progression free survival

Side effects data

From 2022 Phase 2 trial • 46 Patients • NCT02448225

Dyspnea

Non-cardiac chest pain

Pneumothorax

100%

80%

60%

40%

20%

Study treatment Arm

Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blood Draw

2014

Completed Phase 4

~2350

Fluorine F 18 L-glutamate Derivative BAY94-9392

2015

Completed Phase 2

~50