Malignant Melanoma
Conditions
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.
Interventions
DRUG68Ga-PSMA
This is an imaging radionuclide tracer and is in chemical form. Up to 200 MBq. Route of administration is Intravenous.
Sponsors
Royal Marsden NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All patients will receive PSMA-PET-CT
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSMA PET-CT detection of melanoma metastases | 1 Year | The principal objective of the study is to investigate whether the diagnostic biomarker, prostate-specific membrane antigen (PSMA), can detect melanoma metastases using a PSMA PET/ CT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare FDG PET-CT & PSMA PET-CT | 1 Year | 1. To compare FDG PET-CT in identifying known metastasis with PSMA PET-CT 2. To compare the radiological information obtained by FDG PET-CT and PSMA PET-CT |
Countries
United Kingdom
Contacts
Primary ContactReyhaneh Sadegh Zadeh
Outcome results
None listed