A Pilot Study of Glutamine PET Imaging of Head and Neck Squamous Cell Carcinoma

• Status: Not yet recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center

Criteria

Inclusion Criteria:

1. ≥18 years of age;

2. Pathologically or cytologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC);

3. Documented results from (or scheduled to undergo) CT or MRI as a SOC procedure within 28 days prior to baseline investigational 11C-Gln PET/CT and 18F-FSPG PET/CT;

4. 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.

5. Ability to provide written informed consent in accordance with institutional policies.

Exclusion Criteria:

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

2. Pregnant or lactating females.

3. Have an allergy to intravenous contrast

4. eGFR<30