Status:
TERMINATED
A Pilot Study of Glutamine PET Imaging of Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Head and Neck Squamous Cell Carcinoma
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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...
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 PE...
Eligibility Criteria
Inclusion
- ≥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
Exclusion
- 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
Key Trial Info
Start Date :
September 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2025
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05322135
Start Date
September 14 2022
End Date
March 7 2025
Last Update
April 9 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030