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A feasibility study on Cerenkov Luminescence Imaging during prostate cancer surgery using Gallium-68 PSMA

Cerenkov Luminescence Imaging using Gallium-68 PSMA during Prostate cancer Surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28042
Enrollment
30
Registered
2019-11-04
Start date
2019-05-22
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary prostate cancer

Interventions

Intravenous 68Ga-PSMA injection and ex vivo CLI imaging of excised prostate specimen.

Sponsors

This research is supported by KWF Kankerbestrijding and Technology Foundation STW, as part of their joint strategic research programme ‘Technology for Oncology’ (Grant number 15175).
Lead Sponsor

Eligibility

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 1.5cm 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

MeasureTime frame
The objective of this study is to assess the feasibility of 68Ga-PSMA CLI for intra-operative analysis of prostate surgical specimens.

Secondary

MeasureTime frame
Radiation dosimetry to the OR personnel during the radical prostatectomy .

Contacts

Public ContactJudith olde Heuvel

Netherlands Cancer Institute - Antoni van Leeuwenhoek

j.olde.heuvel@nki.nl0205127843

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)