Clinical trial · Observational
Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Results obtained on the first 8 patients shown an expected glandular membrane specific labeling associated with non-specific labeling of fibro-muscular tissue.
Summary
Brief summary (as posted)
In this study, we aim to evaluate the feasibility of anti-PSMA labelling to detect post-operative prostatic tissues by two ex vivo fluorescence techniques. We will evaluate the feasibility and detection of anti-PSMA labelling by: 1. / the FEMTO-ST institute medical device, 2. / the confocal microscope that will be used to measure fluorescence spectra of biological samples.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Prostate | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorescence assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Experimental: fluorescence assessment
- description
- Medical device: Use of the FEMTO-ST institute medical device to detect prostatic and non prostatic tissue.
- interventionNames
- Other: Fluorescence assessment
Primary outcomes (1)
- measure
- Comparison of the fluorescence obtained using the FEMTO-ST device and the confocal microscope of anti-PSMA marked fresh prostate biopsies, for prostatic and non-prostatic tissue, as identified by anatomo-pathology (gold standard).
- timeFrame
- 14 months
- description
- Fluorescence measurements obtained using the FEMTO-ST medical device and the confocal microscope.
Secondary outcomes (1)
- measure
- Comparison of the fluorescence obtained using the FEMTO-ST device and the confocal microscope of anti-PSMA marked fresh prostate biopsies, for cancerous and non-cancerous tissue, as identified by anatomo-pathology (gold standard).
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * male patient over 18 years old * patient with indication for radical prostatectomy * patient with a rectal palpable nodule or targeted MRI positive biopsies or with at least 4 positive biopsies in a hemi-prostate. * patient affiliated to French social security system or equivalent * patient who have signed a non-opposition form Exclusion Criteria: * patient with contraindication to radical prostatectomy * patient with remedial prostatectomy * patient with normal preoperative MRI or with absence of tumoral area * patient with history of hormonal therapy * person deprived of freedom by judicial or administrative decision * person under legal protection * person hospitalized for psychiatric care.
References
Publications (0)
Data not yet available