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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT05522257
Eligibility Criteria:
Inclusion Criteria:
* Age \>/= 18 years at the time of informed consent.
* Diagnosis of advanced (locally irresectable or metastasized) soft tissue sarcoma (cohort 1) or advanced (muscle invasive or metastasized) urothelial cell carcinoma (cohort 2).
* Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
* Recent (\< 8 weeks) standard imaging (with CT or \[18F\]-FDG PET/CT) with measurable disease (lesion diameter \> 1 cm).
* Biopsy available of primary tumour and/or metastasis
* WHO performance status of 0-2
* Either:
* No previous systemic therapy for advanced soft tissue sarcoma or advanced urothelial cell carcinoma, or;
* Previous systemic therapy for advanced soft tissue sarcoma or advanced urothelial cell carcinoma with progression of disease during systemic therapy or progression of disease after discontinuation of systemic therapy, or;
* Previous systemic therapy for advanced soft tissue sarcoma or advanced urothelial cell carcinoma with partial response or stable disease, where the last dose of systemic therapy was given \> 8 weeks before.
Exclusion Criteria:
* Women who are pregnant and/or lactating.
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
* Known hypersensitivity to drugs comparative to \[18F\]-JK-PSMA-7, any of their excipients or to any component of \[18F\]-JK-PSMA-7.
* Inability to undergo PET/CT scanning, e.g. claustrophobia, weight limits or inability to tolerate lying down for the duration of a PET/CT scan (\~30 minutes).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05522257
Study Brief:
Protocol Section:
NCT05522257