Status:
RECRUITING
Preoperative Planning With PSMA-PET in Melanoma Surgery Trial
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Conditions:
Malignant Melanoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This is a non-randomised, single-centre Phase 2 study, investigating whether the diagnostic biomarker, prostate-specific membrane antigen (PSMA), can detect melanoma metastases using PSMA PET/ CT.
Detailed Description
The proposed 'Preoperative Planning PSMA-PET in Melanoma Surgery (PPPIMS)' trial is a Phase 2 study, investigating the ability of PSMA as a biomarker to accurately detect melanoma metastases in patien...
Eligibility Criteria
Inclusion
- Males ≥18 years of age
- Biopsy proven first and recurrent metastatic melanoma with palpable nodal disease who have undergone a staging FDG PET-CT scan as part of routine clinical care and are scheduled for surgery for resection of the primary site
Exclusion
- Patients unable to give voluntary written informed consent to participate in this study
- Patients not willing to complete all the study assessments
- Patients who are females
- Patients who are taking androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists.
- Patients who have or have previously been diagnosed with prostate cancer
- Patients who have had Lu-177 PSMA therapy or barium studies within a period of 10 days prior to undergoing PSMA PET-CT scanning
- Patients not fluent in English
Key Trial Info
Start Date :
March 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06560905
Start Date
March 11 2025
End Date
December 31 2025
Last Update
July 1 2025
Active Locations (1)
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1
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ