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

April 7, 2025 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Primary Objective:

The primary objective of this trial is to evaluate the ability of 11C-Gln and 18F-FSPG PET imaging to detect tumors in patients with HNSCC.

Hypotheses: 11C-Gln PET and 18F-FSPG PET will yield standardized uptake values SUVs; within HNSCC primary and metastatic lesions that are significantly higher relative to SUV of background tissue.

Primary Outcome Measures

11C-Gln standardized uptake value (SUV) including SUVmax, SUVpeak, and SUVmean for tumors and normal tissue 18F-FSPG standardized uptake value (SUV) including SUVmax, SUVpeak, and SUVmean for tumors and normal tissue

Secondary Objectives:

A secondary objective of this trial is to compare PET imaging data to standard-of-care MRI or CT. Another secondary objective is to determine the tumor-to-background ratios (TBR) for 11C-Gln and 18F-FSPG. A third secondary objective is to determine the safety of 11C-Gln.

Hypotheses: 11C-Gln PET and 18F-FSPG PET will detect additional sites of disease that are not visualized by CT or MRI. In addition, tumor-to-background ratios (TBR) for either tracer will exceed 2. Finally, 11C-Gln will be safe at the doses administered in this study.

Secondary Outcome Measures:

Number of lesions. Lesion count will be determined on a per patient basis. Tumor size (e.g., long-axis diameter, short-axis diameter, tumor volume) derived from standard-of-care (SOC) CT or MRI. Tumor size will be defined according to RECIST v1.1 [10] with the longest diameter measured for tumor lesions and the short-axis diameter measured for malignant lymph nodes.

Tumor-to-background ratios (TBR) for 11C-Gln and 18F-FSPG Adverse events associated with 11C-Gln

Exploratory Objectives:

An exploratory objective of this trial is to compare 11C-Gln PET/CT and 18F-FSPG PET/CT imaging to conventional 18F-FDG PET when feasible. Another exploratory objective is to compare uptake of 11C-Gln and 18F-FSPG between HPV-positive and HPV-negative patients.

Hypothesis: The SUVmax and TBR for 11C-Gln PET or 18F-FSPG PET will be greater than 18F-FDG PET. We also hypothesize based on the published expression data that 11C-Gln and 18F-FSPG avidity will differ between HPV-positive and negative patients, with 11C-Gln having higher uptake in HPV-positive patients, while 18F-FSPG will have higher uptake in HPV-negative patients.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 42 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.
  6. Non-English speaking subject will be included. Verbal Translation Preparative Sheet (VTPS) short form will be utilized in consent non-English speaking subject

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET scan
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
Given by vein (IV)
Drug: 11C-Glutamine
Given by vein (IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To establish the ability of 11C-Gln PET imaging to detect tumors in patients with (HNSCC) Head and Neck Squamous Cell Carcinoma NSCC.
Time Frame: through study completion, an average of 1 year
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.
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Lesley Flynt, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2022

Primary Completion (Actual)

March 7, 2025

Study Completion (Actual)

March 7, 2025

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 11, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0739
  • NCI-2022-02415 (Other Identifier: Clinical Trials Reporting Program)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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