Using PSMA-PET to guide melanoma surgery planning
Preoperative Planning With PSMA-PET in Melanoma Surgery Trial
We will see if a PSMA PET/CT scan can find melanoma spread more clearly than the standard FDG PET/CT in adults with palpable lymph nodes or limited metastatic melanoma who are scheduled for surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Royal Marsden NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06560905 on ClinicalTrials.gov |
What this trial studies
This is a non-randomised, single-centre Phase 2 imaging study comparing 68Ga-PSMA PET/CT with the standard FDG PET/CT in patients with palpable nodal disease or oligometastatic melanoma. Participants (male adults) will undergo PSMA PET/CT in addition to their routine FDG PET/CT, with imaging findings compared to intraoperative findings and pathology where available. The trial aims to determine whether PSMA imaging can improve 3D lymphatic mapping and better delineate nodal disease in complex anatomical areas. Improved lesion detection could inform more precise surgical planning and potentially reduce the extent of dissection and operative morbidity.
Who should consider this trial
Good fit: Adult men (≥18) with biopsy-proven primary or recurrent metastatic melanoma who have palpable lymph node disease or limited metastases, have had an FDG PET/CT, and are scheduled for surgical resection are ideal candidates.
Not a fit: Women, patients with widespread metastatic disease, those with prior prostate cancer or on androgen-deprivation therapies, or patients unable to undergo PET/CT are unlikely to benefit from this PSMA-PET approach.
Why it matters
Potential benefit: If successful, PSMA-PET could improve detection of melanoma metastases and enable more precise surgical planning that reduces the extent of dissection and related morbidity.
How similar studies have performed: PSMA-PET is well established in prostate cancer but its application to melanoma is novel with only limited preliminary reports and no large-scale validation to date.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London
- The Royal Marsden NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Myles Smith — Royal Marsden NHS Foundation Trust
- Study coordinator: Reyhaneh Sadegh Zadeh
- Email: reyhaneh.sadeghzadeh@rmh.nhs.uk
- Phone: 020 7352 8171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.