Clinical trial · Interventional
Preoperative Planning With PSMA-PET in Melanoma Surgery Trial
NCT06560905CI-TRIAL-00091644PPPIMSrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-PSMA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PSMA PET-CT
- description
- Within 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.
- interventionNames
- Drug: 68Ga-PSMA
Primary outcomes (1)
- measure
- PSMA PET-CT detection of melanoma metastases
- timeFrame
- 1 Year
- description
- 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.
Secondary outcomes (1)
- measure
- Compare FDG PET-CT & PSMA PET-CT
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.