Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560905
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Preoperative Planning With PSMA-PET in Melanoma Surgery Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Preoperative Planning With PSMA-PET in Melanoma Surgery Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPPIMS
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None