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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
16
This is an imaging radionuclide tracer and is in chemical form. Up to 200 MBq. Route of administration is Intravenous.
The Royal Marsden NHS Foundation Trust
London, United Kingdom
RECRUITINGPSMA PET-CT detection of melanoma metastases
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.
Time frame: 1 Year
Compare FDG PET-CT & PSMA PET-CT
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
Time frame: 1 Year
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