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

NCT05322135 | Terminated Early Phase 1 DMC FDA Drug

• 2 other identifiers: 2021-0739NCI-2022-02415
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Squamous Cell Carcinoma; Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

• To establish the ability of 11C-Gln PET imaging to detect tumors in patients with (HNSCC) Head and Neck Squamous Cell Carcinoma NSCC.

  through study completion, an average of 1 year

• To establish the ability of the 18F-FSPG PET imaging to detect tumors in patients with (HNSCC) Head and Neck Squamous Cell Carcinoma NSCC.

  through study completion, an average of 1 year

Study Arms (1)

PET scan

EXPERIMENTAL

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).

Drug: 18F-FSPG; Drug: 11C-Glutamine

Interventions

18F-FSPG DRUG

Given by vein (IV)

PET scan

11C-Glutamine DRUG

Given by vein (IV)

PET scan

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 head and neck squamous cell carcinoma (HNSCC);
• Documented results from (or scheduled to undergo) CT or MRI as a SOC procedure within 42 days prior to baseline investigational 11C-Gln PET/CT and 18F-FSPG PET/CT;
• 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.
• Ability to provide written informed consent in accordance with institutional policies.
• Non-English speaking subject will be included. Verbal Translation Preparative Sheet (VTPS) short form will be utilized in consent non-English speaking subject

You may not qualify if:

• Body weight ≥400 pounds or body habitus or disability that will not permit the imaging protocol to be performed;
• Pregnant or lactating females.
• Have an allergy to intravenous contrast
• eGFR\<30

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

4-(3-fluoropropyl)glutamic acid

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Study Officials

• Lesley Flynt, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 11, 2022
• Study Start: September 14, 2022
• Primary Completion: March 7, 2025
• Study Completion: March 7, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

US (1)