Preoperative planning PSMA-PET in Melanoma Surgery (PPPIMS)

Phase 2

• Conditions: Metastatic melanoma; Cancer

• Registration Number: ISRCTN20735014
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-09-26
• Last Update Posted: 30 September 2024
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

1. Males =18 years of age 2. 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

1. Patients unable to give voluntary written informed consent to participate in this study2. Patients not willing to complete all the study assessments3. Patients who are females4. Patients who are taking androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists5. Patients who have or have previously been diagnosed with prostate cancer6. Patients who have had Lu-177 PSMA therapy or barium studies within a period of 10 days prior to undergoing PSMA PET-CT scanning7. Patients not fluent in English

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Proportion of successes for detecting metastatic disease by PSMA PET-CT, measured at a single timepoint before surgery

Secondary Outcome Measures

Name	Time	Method
1. Proportion of successes for detecting metastatic disease by both PSMA PET-CT and FDG PET-CT, measured at a single timepoint before surgery2. The Standardised Uptake Value (SUV) by both FDG PET-CT and PSMA PET-CT, measured at a single timepoint before surgery