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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT04621435
Eligibility Criteria:
Inclusion Criteria:
1. Age \>= 18 years
2. Histopathologically confirmed solid tumors in one of the following cohorts:
a. Cohort 1 (n=16): measurable disease is not required for this cohort. i. Agnostic to tumor type. b. Cohort 2 (n=40): Metastatic disease present on conventional imaging defined as having RECIST 1.1 measurable disease or multiple bone metastases.
i. Pathologically confirmed breast cancer, pancreatic adenocarcinoma, sarcoma, castrate-resistant prostate cancer, bladder cancer, or colon cancer.
ii. Pathologically confirmed cancer other than noted above (basket subgroup, n=10).
c. Cohort 3 (n=30): No evidence of metastatic disease as defined as the absence of RECIST 1.1 measurable disease or bone metastases.
i. Patients can be imaged at initial staging with what is judged by the treating physician to be high risk disease and where the presence of metastatic disease would greatly impact treatment planning and prognosis. Patients may also be imaged after definitive therapy (surgery, chemotherapy or radiation therapy) if in the determination of the treating physician or investigator there is a high risk of disease recurrence that would also impact treatment plan and/or prognosis.
ii. Pathologically confirmed head and neck cancer or bladder cancer.
3. Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
2. Known pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04621435
Study Brief:
Protocol Section:
NCT04621435