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Looking for participantsPhase2

Preoperative Planning With PSMA-PET in Melanoma Surgery Trial

Sponsor: Royal Marsden NHS Foundation Trust

NCT ID: NCT06560905

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
68Ga-PSMA (drug)
How long the study runs
Study runs about 9 months (dates as stated)
About the drug or intervention
68Ga-PSMA — drug: This is an imaging radionuclide tracer and is in chemical form.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
Male
Number of participants
16
Started
2025-03-11
Last checked
2025-06

Plain English Summary

What is this study?

  • • Testing a new treatment for malignant melanoma
  • • Phase2 - 16 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with malignant melanoma
  • • Male only

Where?

  • • London - The Royal Marsden NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Malignant Melanoma

How this trial compares with your answers

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What we know so far

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Male only

What the study is looking for

  • ✓Males ≥18 years of age

Who cannot take part

  • ✗Patients unable to give voluntary written agreement to take part 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...
  • ✗Patients who have or have previously been diagnosed with prostate cancer
See the full 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 Is This Study? (1 UK site)

The Royal Marsden NHS Foundation Trust

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Myles SmithPrincipal Investigator
Reyhaneh Sadegh Zadehreyhaneh.sadeghzadeh@rmh.nhs.uk

How to Get in Touch

Reyhaneh Sadegh Zadeh

Sponsor contact

CONTACT

020 7352 8171 reyhaneh.sadeghzadeh@rmh.nhs.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-06