Preoperative Planning With PSMA-PET in Melanoma Surgery Trial
PPPIMS
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2025
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2024
CompletedFirst Posted
Study publicly available on registry
August 19, 2024
CompletedStudy Start
First participant enrolled
March 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJuly 1, 2025
June 1, 2025
10 months
August 15, 2024
June 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
PSMA PET-CT detection of melanoma metastases
The principal objective of the study is to investigate whether the diagnostic biomarker, prostate-specific membrane antigen (PSMA), can detect melanoma metastases using a PSMA PET/ CT.
1 Year
Secondary Outcomes (1)
Compare FDG PET-CT & PSMA PET-CT
1 Year
Study Arms (1)
PSMA PET-CT
EXPERIMENTALWithin the two weeks prior to surgery, the patients will undergo both PSMA PET-CT \& FDG PET-CT scans at least 48 hours apart. The Investigational Medicinal Product (IMP) under investigation in this trial is 68Ga-PSMA. This is an imaging radionuclide tracer.
Interventions
This is an imaging radionuclide tracer and is in chemical form. Up to 200 MBq. Route of administration is Intravenous.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Myles Smith
Royal Marsden NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2024
First Posted
August 19, 2024
Study Start
March 11, 2025
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
July 1, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ANALYTIC CODE
- Time Frame
- Data requests can be submitted starting 3 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
- Access Criteria
- Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact (surgicalresearchteam@rmh.nhs.uk).
Data obtained through this study may be provided to qualified researchers with academic interest in Melanoma biomarkers. Data or samples shared will be coded, with no patient health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.