Prostate cancer prostate carcinoma
Conditions
Interventions
The administration of 100MBq 68Ga-PSMA prior to CLI imaging.
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the present study is to assess the feasibility of the CLI device as margin assessor intraoperatively in prostate cancer patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Tumour margin status of the prostatectomy specimen as determined by LightPath CLI and histopathology • Radiation dosimetry to the OR personnel during the radical prostatectomy • Tumour uptake on 68Ga-PSMA LightPath CLI in comparison to 68Ga-PSMA PET with high resolution • Ease of use of LightPath CLI • Imaging protocol optimization for ex vivo prostate specimens and the determination of the optimal radiation dosage. | — |
Countries
Netherlands
Outcome results
None listed