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FFOCT for the Diagnosis of Prostate Cancer

NCT02394223 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 91

Last updated 2026-03-27

No results posted yet for this study

Summary

Primary objective :

The primary objective is to evaluate the diagnosis performance of FFOCT for cancer detection in patients undergoing TRUS prostate biopsy, as compared to standard pathological evaluation.

Secondary objective:

* Evaluate predictive values of FFOCT for cancer detection on prostate biopsy cores
* Evaluate the value of FFOCT for cancer characterization on prostate biopsy cores
* Evaluate the reproducibility of FFOCT evaluation for cancer detection on prostate biopsy cores
* Evaluate the learning curve of FFOCT evaluation on prostate biopsy cores
* Evaluate FFOCT procedure time

Conditions

  • Patients With PSA Level 4.0 ng/mL

Interventions

PROCEDURE

Full Field Optical Coherence Tomography (FFOCT) procedure

TRUS Prostate biopsy are performed under the care procedure Pathological examination of these prostate biopsy with FFOCT procedure, as compared to standard pathological evaluation

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Nicolas Barry Delongchamps · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-27
Primary Completion
2017-01-27
Completion
2017-01-27

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02394223 on ClinicalTrials.gov