Head and Neck Squamous Cell CarcinomaEarly Phase 1NCT05322135
A Pilot Study of Glutamine PET Imaging of Head and Neck Squamous Cell Carcinoma
A Early Phase 1 study testing 18F-FSPG and 11C-Glutamine in people with Head and Neck Squamous Cell Carcinoma and Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer
- What is being tested?
- 18F-FSPG and 11C-Glutamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2022to 7 Mar 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- 18F-FSPG, 11C-Glutamine
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FSPGDrug
Given by vein (IV)
11C-GlutamineDrug
Given by vein (IV)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: 18F-FSPG; Drug: 11C-Glutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the ability of 11C-Gln PET imaging to detect tumors in patients with (HNSCC) Head and Neck Squamous Cell Carcinoma NSCC.
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start14 Sep 2022
- Primary completion7 Mar 2025
- Study completion7 Mar 2025
Why it stopped: PI Request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lesley Flynt, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322135
- Sponsor's protocol ID
- 2021-0739
- Other IDs
- NCI-2022-02415
- Status last verified
- Apr 2025
- First submitted
- 15 Mar 2022
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Glutamine PET Imaging of Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05322135
- Acronym / sponsor ID
- 2021-0739
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI Request
- Enrolment
- 3 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 7 Mar 2025 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET scan | Experimental | Drug: 18F-FSPG, Drug: 11C-GlutaminePET 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FSPGGiven by vein (IV) | Drug | PET scan |
| 11C-GlutamineGiven by vein (IV) | Drug | PET scan |
Primary outcome
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
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
Results and safety
The study was stopped early (reason given: PI Request). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lesley Flynt, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18F-FSPG and 11C-Glutamine in people with Head and Neck Squamous Cell Carcinoma and Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI Request). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.