NCT06560905

Preoperative Planning With PSMA-PET in Melanoma Surgery Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 patients with palpable lymphadenopathy and oligometastatic melanoma. If proven to have diagnostic utility, it may allow more precise 3D lymphatic mapping and identification of tumour in intricate anatomical areas, resulting in more accurate surgical planning. A more precise delineation of nodal disease and metastasis will result in a more accurate and lesser surgical dissection, and consequent reduction in morbidity. The PSMA-PET-CT will be compared with the standard-of-care imaging, FDG-PET-CT to evaluate utility of this approach. It is of note that FDG-PET CT has a high background FDG uptake normally seen in the brain and liver, and PSMA could potentially be a more favourable tracer if there is less background uptake.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	68Ga-PSMA	This is an imaging radionuclide tracer and is in chemical form. Up to 200 MBq. Route of administration is Intravenous.

Timeline

• Start date: 2025-03-11
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-08-19
• Last updated: 2025-07-01

Locations

1 site across 1 country: United Kingdom