Interest of Indocyanine Green in Neoplastic Prostatic Tissue

NCT ID: NCT02260349

Last Updated: 2016-03-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-02-29

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.

Conditions

Prostatic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patient with Indocyanine green infusion

Infusion of Indocyanine Green 0,25 mg/Kg 24h before prostatic surgery

Group Type: EXPERIMENTAL

indocyanine green infusion

Intervention Type: DRUG

intravenous injection (0,25mg/kg) of the indocyanine green 24h before prostatic surgery.

Interventions

indocyanine green infusion

intravenous injection (0,25mg/kg) of the indocyanine green 24h before prostatic surgery.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas MOTTET, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Other Identifiers

2014-000218-67

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1308190

Identifier Type: -

Identifier Source: org_study_id