Clinical trial NCT02260349: Interest of Indocyanine Green in Neoplastic Prostatic Tissue
Official title: Interest of Indocyanine Green in the Neoplastic Prostatic Tissue Characterization and the Peroperative Surgical Margins Detection During a Radical Prostatectomy.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Prostatic Neoplasms
Keywords: Prostatic Neoplasms
Prostate cancer
surgical margins
indocyanine green
characterization
prostatectomy
peroperative
detection
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2014-10-09
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Sensitivity of indocyanine green
timeFrame: 24h after indocyanine green infusion
Secondary outcomes:
measure: Specificity of indocyanine green
timeFrame: 24h after indocyanine green infusion
Other outcomes:
Locations:
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Nicolas MOTTET, PhD
role: PRINCIPAL_INVESTIGATOR
References: