NL-OMON54064
Recruiting
Phase 2
Expression of prostate specific membrane antigen (PSMA) in soft tissue sarcomas and urothelial cell carcinomas: implications for tumour-specific molecular imaging and treatment? - PSMA expression & PSMA PET in soft tissue sarcoma/urothelial cell carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- bladder cancer
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 120
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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
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
Outcomes
Primary Outcomes
Not specified
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