Interest of Indocyanine Green in Neoplastic Prostatic Tissue

Phase 3

Withdrawn

• Conditions: Prostatic Neoplasms
• Interventions: Drug: indocyanine green infusion

• Registration Number: NCT02260349
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Prostate cancer, with more than 70,000 new cases and 8900 deaths a year in France, is a major public health problem. Until 28% of patients treated with surgery will present a positive surgical margin resulting in an incomplete clearance of the tumoral process and exposing so the patient at a local, systemic recurrence and increased morbidity. An increasing number of international publications have shown (ICG) was interesting for the detection of the sentinel lymph node, in the surgery of tumors of type hepatocarcinoma and liver metastases from colorectal diseases, but also in the surgery of the kidney, bladder or breast. ICG has affinity for tumor and tissues around the tumor related to micro-vascular histology for a localized and specific deposit (EPR effect).

The detection of ICG 's deposits is now possible with to the use of a device which allow to visualize the infra-red fluorescence (NIR; Near Infra-Red) for objects larger than 0.15 mm. Thanks to this feature, the location of residual tumor tissue when performing a radical prostatectomy could be made much easier.

Detailed Description

The ability of ICG to detect a surgical margin positive intraoperatively has never be evaluated. We want to perform a monocentric prospective ex-vivo pilot in order to evaluate the diagnostic performance of fluorescence in the detection of surgical margins compared to pathologic analysis. This study will be conducted in 37 patients operated on for a radical prostatectomy after systemic injection of 0, 25 mg/Kg of ICG 24 h before the surgery. The fluorescence analysis will be performed in the operation room and then specimen will be sent to the laboratory for an analysis as usual. Two pieces of prostate will be prelevated according to a protocol. The histopathological procedure will be performed without knowledge of fluorescence analysis. Except the ICG injection the medical procedure won't be changed.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-09
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-09
• Last Update Posted: 2016-03-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with prostatic cancer proved by biopsy and needing total prostatectomy with or without curettage.
• Patient affiliated to a social security scheme
• Patient has given its informed consent

Exclusion Criteria

• contra-indication to surgery
• non confirmed adenocarcinoma diagnostic
• antecedent of prostatic cancer treatment
• antecedent of pelvic surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patient with Indocyanine green infusion	indocyanine green infusion	Infusion of Indocyanine Green 0,25 mg/Kg 24h before prostatic surgery

Primary Outcome Measures

Name	Time	Method
Sensitivity of indocyanine green	24h after indocyanine green infusion	Sensitivity (true positive) of the fluorescence due to indocyanine green to detect neoplasm tissue in prostatic biopsy compared to histological analysis

Secondary Outcome Measures

Name	Time	Method
Specificity of indocyanine green	24h after indocyanine green infusion	Specificity (true negative) of the fluorescence due to indocyanine green to detect neoplasm tissue in prostatic biopsy compared to histological analysis