Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-24 @ 10:19 PM
NCT ID:
NCT05322135
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05322135
Study Brief:
Protocol Section:
NCT05322135