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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new imaging technique for head and neck cancer, specifically using PET scans with two substances, 11C-Glutamine and 18F-FSPG, to assess their effectiveness in showing cancer activity. The goal is to gather more information on how these imaging agents spread in the body and to ensure their safety, as no side effects have been noted so far. People with head and neck squamous cell carcinoma (a type of cancer) who have had or are scheduled for a CT or MRI scan may be suitable for this study. As an Early Phase 1 trial, this research focuses on understanding how these imaging agents work in people, offering participants the opportunity to be among the first to benefit from this innovative technique.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this imaging technique is safe for head and neck cancer patients?

Research has shown that the imaging techniques being tested, called 11C-Glutamine and 18F-FSPG PET scans, are safe. In studies so far, 11C-Glutamine has shown no side effects. This substance, a type of amino acid naturally used by the body, is administered in very small amounts, making harm unlikely.

The 18F-FSPG PET scan is also under study, and similar research has reported no safety issues. Both techniques, still in early testing stages, are closely monitored for any problems. So far, evidence suggests that patients tolerate these scans well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to see head and neck cancer using PET imaging with 11C-Glutamine and 18F-FSPG. Unlike traditional imaging methods like CT or MRI scans, these PET scans use radioactive materials to highlight cancer cells' unique behavior, potentially offering a clearer picture of the cancer's metabolic activity. This could lead to earlier and more accurate detection, helping doctors tailor treatments more effectively and improving outcomes for patients.

What evidence suggests that this imaging technique is effective for head and neck cancer?

This trial will compare two PET imaging methods for head and neck cancer: 11C-Glutamine PET and 18F-FSPG PET. Research has shown that 11C-Glutamine PET imaging might help detect head and neck cancer by tracking glutamine, a nutrient essential for cancer cell growth. Early studies indicate that cancer cells often rely on glutamine, and this imaging can identify where these cells concentrate. Meanwhile, 18F-FSPG PET imaging has shown potential in detecting changes in cancer cells early during treatment. Research has found that it can observe tumor responses to treatments even before they begin to shrink. Although more research is needed, these imaging methods could offer new ways to monitor treatment effectiveness for head and neck cancer. ^{1 2 4 5 6}

Who Is on the Research Team?

Lesley Flynt, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05322135?tab=table

A Pilot Study of Glutamine PET Imaging of Head and Neck ... 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.

2. cancer.gov cancer.gov/clinicaltrials/NCI-2022-02415

Investigational Scans (11C-Glutamine or 18F-FSPG PET ... This early phase I trial studies two new imaging techniques called 11C-glutamine positron emission tomography (PET) and 18F-FSPG PET to determine where and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0006295225004678

Molecular PET imaging: Unlocking the secrets of cancer ... This review explores the foundational principles of PET imaging, highlighting key radiotracers such as [18F]-FDG, glutamine-based tracers, and hypoxia-sensitive ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7455665/

l-glutamate (FSPG) PET/CT imaging in patients with head ... [18F]FSPG PET/CT showed promising results across 15 subjects with 3 different cancer types. Concordant visualization was mostly observed between ...

5. biosignaling.biomedcentral.com biosignaling.biomedcentral.com/articles/10.1186/s12964-024-02018-6

Glutamine and cancer: metabolism, immune ... In preclinical studies, cancer cells were dependent on glutamine, and glutaminase inhibition led to reduced cell growth and induced apoptosis [ ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12210561/

Targeting glutamine metabolism as a potential target for ... This review demonstrates that glutamine metabolism is a pivotal factor in the development of malignant phenotypes in tumors by modulating multifaceted ...