NCT05522257Completed
PSMA Expression and PSMA PET Imaging in Soft Tissue Sarcomas and Urothelial Cell Carcinomas
Expression of Prostate Specific Membrane Antigen (PSMA) in Soft Tissue Sarcomas and Urothelial Cell Carcinomas: Implications for Tumour-specific Molecular Imaging and Treatment?
Source: ClinicalTrials.gov · Last updated 9 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 16 Aug 2022
- Start date
- 1 Aug 2022
- Primary completion date
- 22 Jul 2024
- Lead sponsor
- Leiden University Medical Center
- Diseases
- Prostate cancer, Bladder cancer, Sarcoma
- NCT number
- NCT05522257
What you commit to
- Study type: Interventional
- Participants enrolled: 25
- From 1 Aug 2022 to the primary completion date, 22 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Women who are pregnant and/or lactating.
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Leiden University Medical Centre Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.