PPPIMS

• Research type

  Research Study

• Full title

  Preoperative planning PSMA-PET in Melanoma Surgery (PPPIMS)

• IRAS ID

  1005470

• Contact name

  Myles Smith

• Contact email

  myles.smith@rmh.nhs.uk

• Sponsor organisation

  The Royal Marsden NHS Foundation Trust

• Eudract number

  2022-001208-16

• ISRCTN Number

  ISRCTN20735014

• Clinicaltrials.gov Identifier

  NCT06560905

• Research summary

  This study is a prospective, single-centre clinical trial investigating the ability of a new diagnostic biomarker, prostate specific
  membrane antigen (PSMA) to detect melanoma metastases using a PSMA PET/CT.

  This study aims to recruit 16 patients with operable advanced metastatic melanoma and will be identified at a routine
  clinical outpatient appointment. They will undergo the standard preoperative scans determined by the consultant;
  either whole body PET/ CT or FDG-PET/ CT and MRI brain, with the addition of the PSMA PET/ CT scan, investigating
  the presence of metastases. The patients will then undergo surgery determined by the patient’s Consultant.

  The PSMA-PET scans will be carried out in the Nuclear Medicine Department at the Royal Marsden Hospital and
  interpreted by a Consultant Radiologist with a special interest in Nuclear Medicine. These will be compared to the
  standard-of-care scans. This is a phase 2 study to determine the efficacy of PSMA PET/CT in identifying metastatic disease in melanoma patients. If there is no PSMA activity identified by the first five patients, we will terminate the trial.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  24/SC/0279

• Date of REC Opinion

  9 Aug 2024

• REC opinion

  Favourable Opinion