Preoperative Planning With PSMA-PET in Melanoma Surgery Trial

NCT ID: NCT06560905

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-11
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PSMA PET-CT

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.

Group Type: EXPERIMENTAL

68Ga-PSMA

Intervention Type: DRUG

This is an imaging radionuclide tracer and is in chemical form. Up to 200 MBq. Route of administration is Intravenous.

Interventions

68Ga-PSMA

This is an imaging radionuclide tracer and is in chemical form. Up to 200 MBq. Route of administration is Intravenous.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Myles Smith

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

The Royal Marsden NHS Foundation Trust

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Reyhaneh Sadegh Zadeh

Role: CONTACT

reyhaneh.sadeghzadeh@rmh.nhs.uk

020 7352 8171

Facility Contacts

Reyhaneh Sadegh Zadeh

Role: primary

reyhaneh.sadeghzadeh@rmh.nhs.uk

Other Identifiers

CCR5614

Identifier Type: -

Identifier Source: org_study_id