Interest of Indocyanine Green in Neoplastic Prostatic Tissue

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02260349
• Other study ID #: 1308190
• Secondary ID: 2014-000218-67
• Status: Withdrawn
• Phase: Phase 3
• First received: September 25, 2014
• Last updated: March 9, 2016
• Start date: April 2014
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Specificity of indocyanine green	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	No