Preoperative Planning With PSMA-PET in Melanoma Surgery Trial
Recruiting · NCT06560905 · Interventional (participants receive a specific treatment) · Lead sponsor: Royal Marsden NHS Foundation Trust
View the official record on ClinicalTrials.gov →Interventions studied
68Ga-PSMA
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- The Royal Marsden NHS Foundation Trust - London, United Kingdom