A feasibility study on Cerenkov Luminescence Imaging using Gallium-68 PSMA during prostate cancer surgery
Recruiting
- Conditions
- Prostate cancerprostate carcinoma1003695810025506
- Registration Number
- NL-OMON48989
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
- Primary prostate cancer >18 year, eligible for PSMA PET scan (PSA>=20 ng/mL
or >=cT3 or Gleason>=7)
- Tumour larger than 2cm on MRI.
- Signed informed consent
- Voluntary understanding
- Scheduled for radical prostatectomy surgery
- PSMA uptake on pre-operative 68Ga-PSMA PET scan
Exclusion Criteria
- Usage of Indocyanine green (ICG) during surgery
- No PSMA uptake on clinical PET/CT-scan
- Subjects who have an existing medical condition that would compromise their
participation in the study
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of the present study is to assess the feasibility of the<br /><br>CLI device as margin assessor intraoperatively in prostate cancer patients.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Tumour margin status of the prostatectomy specimen as determined by LightPath<br /><br>CLI and histopathology<br /><br>• Radiation dosimetry to the OR personnel during the radical prostatectomy<br /><br>• Tumour uptake on 68Ga-PSMA LightPath CLI in comparison to 68Ga-PSMA PET with<br /><br>high resolution<br /><br>• Ease of use of LightPath CLI<br /><br>• Imaging protocol optimization for ex vivo prostate specimens and the<br /><br>determination of the optimal radiation dosage. </p><br>
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms enable Cerenkov Luminescence Imaging (CLI) with Gallium-68 PSMA to detect prostate cancer during surgery?
How does intraoperative CLI using Gallium-68 PSMA compare to standard-of-care imaging techniques in prostate cancer radical resection?
Which PSMA expression biomarkers correlate with enhanced CLI signal detection in prostate carcinoma patients?
What radiation safety protocols are implemented for Gallium-68 PSMA CLI in the Antoni van Leeuwenhoek Ziekenhuis observational trial?
Are there alternative PSMA-targeting radiotracers or imaging modalities being evaluated for prostate cancer surgery alongside Gallium-68?