Interest of Indocyanine Green in Neoplastic Prostatic Tissue

NCT02260349 | Withdrawn Phase 3

• 2 other identifiers: 13081902014-000218-67
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostatic Neoplasms

Keywords

Prostatic Neoplasms; Prostate cancer; surgical margins; indocyanine green; characterization; prostatectomy; peroperative; detection

Outcome Measures

Primary Outcomes (1)

• Sensitivity of indocyanine green

  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 Outcomes (1)

• Specificity of indocyanine green

  24h after indocyanine green infusion

Study Arms (1)

patient with Indocyanine green infusion

EXPERIMENTAL

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

Drug: indocyanine green infusion

Interventions

indocyanine green infusion DRUG

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

patient with Indocyanine green infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

MeSH Terms

Conditions

Prostatic Neoplasms; Margins of Excision

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicolas MOTTET, PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: October 9, 2014
• Study Start: April 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 10, 2016

Record last verified: 2016-03