Preoperative Planning With PSMA-PET in Melanoma Surgery Trial

Trial Title: Preoperative Planning With PSMA-PET in Melanoma Surgery Trial

NCT ID: NCT06560905

Condition: Malignant Melanoma

Conditions: Official terms:
Melanoma
Gallium 68 PSMA-11

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: All patients will receive PSMA-PET-CT

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: 68Ga-PSMA
Description: This is an imaging radionuclide tracer and is in chemical form. Up to 200 MBq. Route of administration is Intravenous.
Arm group label: PSMA PET-CT

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.

Criteria for eligibility:
Criteria:
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

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: September 1, 2024

Completion date: December 15, 2025

Lead sponsor:
Agency: Royal Marsden NHS Foundation Trust
Agency class: Other

Source: Royal Marsden NHS Foundation Trust

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06560905