Glutamine PET Imaging for Head and Neck Cancer

Overseen By Lesley Flynt, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Obesity, Pregnancy, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

3 Participants Needed

Trial Summary

What is the purpose of this trial?

We propose a focused, prospective pilot clinical imaging trial to evaluate 11C-Gln PET/CT followed by 18F-FSPG PET/CT in 20 HNSCC patients. Imaging metrics that are common to PET (e.g. SUVmax, peak or mean) will be determined. This study will also allow the acquisition of additional safety and biodistribution data, as, to date, only a limited number of patients have been evaluated with 11C-Gln as a direct PET imaging biomarker of Gln uptake. To date, no adverse side effects have been observed. We do not anticipate any toxicity since this tracer is a naturally-occurring essential amino acid in high abundance and is administered at sub-pharmacologic doses. A long-term goal of these preliminary studies is to validate the utility of Gln PET imaging metrics for HNSCC and to expand this imaging technique to additional patients in prospective cohorts of patients with HNSCC.

Research Team

Lesley Flynt, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I do not speak English but can give consent with a translated form.

Measurable disease by RECIST v1.1 defined as tumor lesions with a longest diameter ≥ 10 mm and/or malignant lymph nodes with a short axis diameter ≥ 15 mm

I have had (or will have) a CT or MRI within the last 42 days.

Exclusion Criteria

Have an allergy to intravenous contrast

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

Pregnant or lactating females

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo 11C-Gln PET/CT followed by 18F-FSPG PET/CT scans to evaluate tumor detection

1-2 weeks

2 visits (in-person)

Comparison and Analysis

PET imaging data is compared to standard-of-care MRI or CT, and tumor-to-background ratios are determined

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

Treatment Details

Interventions

• 11C-Glutamine
• 18F-FSPG

Trial Overview 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.

Participant Groups

Group I: PET scan Experimental Treatment 2 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).

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+