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Glutamine PET Imaging for Head and Neck Cancer

Phase < 1

Waitlist Available

Led By Lesley Flynt, MD

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 head and neck squamous cell carcinoma (HNSCC)

Must not have

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 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether a new cancer imaging technique is effective and safe in 20 patients with head and neck squamous cell carcinoma.

Who is the study for?

This trial is for adults over 18 with confirmed head and neck squamous cell carcinoma (HNSCC) who can consent to the study. They must have measurable disease by specific criteria and be able to undergo CT or MRI scans. Pregnant or breastfeeding individuals, those allergic to IV contrast, with poor kidney function, or too large for imaging equipment are excluded.

What is being tested?

The study tests two PET/CT imaging agents, 11C-Glutamine followed by 18F-FSPG, in patients with HNSCC. It aims to evaluate these tracers' effectiveness in measuring tumor uptake of glutamine and gather additional safety data on their use.

What are the potential side effects?

So far, no adverse side effects have been observed from using the tracer agents as they are naturally occurring amino acids given at low doses not expected to cause toxicity.

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 cancer is a type of head and neck cancer confirmed by lab tests.

Exclusion Criteria

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

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I weigh over 400 pounds or have a condition that prevents me from undergoing certain scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: PET scanExperimental Treatment2 Interventions

PET scans: an 11C-Glutamine PET scan and an 18F-FSPG PET scan. A small tube (called an IV) will be placed in a vein in your arm through which you will receive the radioactive material for the PET scan(s).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Florilglutamic acid F-18

Not yet FDA approved

0 / 3Eligibility criteria met