Preoperative Planning With PSMA-PET in Melanoma Surgery Trial
ConditionMalignant Melanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorRoyal Marsden NHS Foundation Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
68Ga-PSMA
DrugThis is an imaging radionuclide tracer and is in chemical form. Up to 200 MBq. Route of administration is Intravenous.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: PSMA PET-CTExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
1 YearSecondary outcomes
1
Compare FDG PET-CT & PSMA PET-CT
1. To compare FDG PET-CT in identifying known metastasis with PSMA PET-CT 2. To compare the radiological information obtained by FDG PET-CT and PSMA PET-CT
Time frame
1 YearSponsors and contacts
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Source ClinicalTrials.gov