A Pilot and Feasibility Study of Indocyanine Green-based Fluorescence Imaging in Localization of Prostate Cancer and Metastatic Lymph Nodes
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- sensitivity and specificity of the ICG-based fluorescence to detect prostate cancer
Study Overview
Brief Summary
This study aims to evaluate the feasibility of indocyanine green (ICG)-based fluorescence imaging in the detection of prostate tumors and metastatic lymph nodes. By correlating the ICG fluorescence patterns with pathologically confirmed tumor and nodal status, it would be possible to use fluorescence navigation system in helping prostate biopsy and lymph node dissection in the future.
Detailed Description
The investigators will conduct an in vivo and in vitro pilot study in order to evaluate the diagnostic performance of fluorescence in the detection of prostate cancer and metastatic lymph nodes. All the patients included in this study will receive a radical prostatectomy after intravenous injection of 0.4 mg/Kg of ICG. ICG will be administered immediately after the patient is anesthetized. The fluorescence analysis will be performed intraoperatively by laparoscopic imaging and after surgery by hand-held imaging. The prostate or lymph nodes specimen with or without fluorescence signal will be sent to the Department of Pathology for pathological analysis. The histopathological procedure will be performed without knowledge of fluorescence analysis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed prostate cancer;
- •Able to accept total prostatectomy;
- •Patient has given its informed consent.
Exclusion Criteria
- •Allergic to ICG or iodine;
- •High-grade hepatic insufficiency
- •refuse attending the study
Arms & Interventions
ICG injection group
ICG will be intravenously administered over a 10 second period immediately after the patient was anesthetized. The fluorescence will be performed during and after the surgery, respectively.
Intervention: Indocyanine Green (ICG) (Drug)
Outcomes
Primary Outcomes
sensitivity and specificity of the ICG-based fluorescence to detect prostate cancer
Time Frame: 1 week post-surgery
sensitivity (true positive) and specificity (true negative) of the ICG-based fluorescence to detect prostate cancer in vivo and in vitro compared to histological analysis
Secondary Outcomes
- sensitivity and specificity of the ICG-based fluorescence imaging to detect metastatic lymph nodes(1 week post-surgery)
Investigators
Rongqin Zheng
Professor
Third Affiliated Hospital, Sun Yat-Sen University