A Phase 3 interventional study of indocyanine green infusion in Prostatic Neoplasms, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Withdrawn. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-10.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Phase 3, Interventional, and Diagnostic
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.
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.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
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Exclusion Criteria:
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.
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
Time frame: 24h after indocyanine green infusion
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
Time frame: 24h after indocyanine green infusion
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The record gives a start of Apr 2014, a primary completion of Feb 2016 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Indocyanine Green
Centre Hospitalier Universitaire de Saint Etienne →