Interest of Indocyanine Green in Neoplastic Prostatic Tissue

March 9, 2016 updated by: Centre Hospitalier Universitaire de Saint Etienne

Interest of Indocyanine Green in the Neoplastic Prostatic Tissue Characterization and the Peroperative Surgical Margins Detection During a Radical Prostatectomy.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patient with Indocyanine green infusion
Infusion of Indocyanine Green 0,25 mg/Kg 24h before prostatic surgery
Drug: indocyanine green infusion
intravenous injection (0,25mg/kg) of the indocyanine green 24h before prostatic surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of indocyanine green
Time Frame: 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
24h after indocyanine green infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity of indocyanine green
Time Frame: 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
24h after indocyanine green infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Nicolas MOTTET, PhD, CHU Saint-étienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

September 25, 2014

First Submitted That Met QC Criteria

October 6, 2014

First Posted (Estimate)

October 9, 2014

Study Record Updates

Last Update Posted (Estimate)

March 10, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1308190
  • 2014-000218-67 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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