Interest of Indocyanine Green in Neoplastic Prostatic Tissue
Primary Purpose
Prostatic Neoplasms
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
indocyanine green infusion
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostatic Neoplasms focused on measuring Prostatic Neoplasms, Prostate cancer, surgical margins, indocyanine green, characterization, prostatectomy, peroperative, detection
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patient with Indocyanine green infusion
Arm Description
Infusion of Indocyanine Green 0,25 mg/Kg 24h before prostatic surgery
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02260349
First Posted
September 25, 2014
Last Updated
March 9, 2016
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT02260349
Brief Title
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
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Scientific coordinator left the hospital
Study Start Date
April 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Prostatic Neoplasms, Prostate cancer, surgical margins, indocyanine green, characterization, prostatectomy, peroperative, detection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient with Indocyanine green infusion
Arm Type
Experimental
Arm Description
Infusion of Indocyanine Green 0,25 mg/Kg 24h before prostatic surgery
Intervention Type
Drug
Intervention Name(s)
indocyanine green infusion
Intervention Description
intravenous injection (0,25mg/kg) of the indocyanine green 24h before prostatic surgery.
Primary Outcome Measure Information:
Title
Sensitivity of indocyanine green
Description
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
Secondary Outcome Measure Information:
Title
Specificity of indocyanine green
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas MOTTET, PhD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Interest of Indocyanine Green in Neoplastic Prostatic Tissue
We'll reach out to this number within 24 hrs