Clinical Trial · NCT05522257

PSMA Expression and PSMA PET Imaging in Soft Tissue Sarcomas and Urothelial Cell Carcinomas

Overview

This pilot study aims to investigate the PSMA expression in the biopsy material of advanced soft tissue sarcomas and advanced urothelial cell carcinomas, and in case of high PSMA expression (as defined by previous literature), to investigate whether this correlates with high tracer uptake on PSMA-targeted PET. This way, (a subset of) patients can be selected that could benefit from radionuclide targeted therapy in the future.

Sponsor

Leiden University Medical Center

Phase

N/A

Contacts

Lioe-Fee De Geus-Oei, prof.dr. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05522257

Drug / Compound

JK-PSMA-7

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Eligibility

Inclusion

* Age \>/= 18 years at the time of informed consent.
Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
Diagnosis of advanced (locally irresectable or metastasized) soft tissue sarcoma (cohort 1) or advanced (muscle invasive or metastasized) urothelial cell carcinoma (cohort 2).
Biopsy available of primary tumour and/or metastasis
Recent (\< 8 weeks) standard imaging (with CT or \[18F\]-FDG PET/CT) with measurable disease (lesion diameter \> 1 cm).

Exclusion

Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
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).
* Women who are pregnant and/or lactating.
Known hypersensitivity to drugs comparative to \[18F\]-JK-PSMA-7, any of their excipients or to any component of \[18F\]-JK-PSMA-7.