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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT05888532
Eligibility Criteria:
Inclusion Criteria:
1. Disease characteristics by cohort, as defined by:
Cohort A:
* Histologically-confirmed metastatic solid tumor malignancy (3 Male, 3 Female)
* Locally advanced or metastatic disease on conventional imaging
Cohort B:
* Histologically-confirmed metastatic renal cell carcinoma (any histologic sub-type) or urothelial carcinoma
* Locally advanced or metastatic disease on conventional imaging
Cohort C:
* Histologically-confirmed prostate adenocarcinoma
* Metastatic castration resistant prostate cancer by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria
2. Planned treatment with immune checkpoint inhibitor (Cohorts B and C only)
3. Willing to undergo paired tumor biopsies and has safely accessible bone or soft tissue lesion (Cohorts B and C only)
4. The subject is able and willing to comply with study procedures and provide signed and dated informed consent.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
6. Age 18 years or older at the time of study entry.
7. Adequate organ function, as defined by:
* Serum creatinine \<= 1.5 x upper limit of normal (ULN) or estimated creatinine clearance \> 60 mL/min
* Total bilirubin \<= 1.5 x ULN (\< 3 x ULN in patients with documented or suspected Gilbert's).
* Hemoglobin \>= 8.0 g/dL
* Platelet count \>= 75,000/microliter
* Absolute neutrophil count ≥ 1000/microliter
8. Patients must not be pregnant or breast feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of PET Imaging scan. Effective contraception (men and women) must be used in subjects of child-bearing potential.
Exclusion Criteria:
1. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
2. Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
3. Is currently pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05888532
Study Brief:
Protocol Section:
NCT05888532