ICG-based Fluorescence Imaging in Localization of Prostate Cancer and Metastatic Lymph Nodes
A Pilot and Feasibility Study of Indocyanine Green-based Fluorescence Imaging in Localization of Prostate Cancer and Metastatic Lymph Nodes
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 5, 2016
CompletedFirst Posted
Study publicly available on registry
July 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedJuly 21, 2016
July 1, 2016
2.8 years
July 5, 2016
July 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sensitivity and specificity of the ICG-based fluorescence to detect prostate cancer
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
1 week post-surgery
Secondary Outcomes (1)
sensitivity and specificity of the ICG-based fluorescence imaging to detect metastatic lymph nodes
1 week post-surgery
Study Arms (1)
ICG injection group
EXPERIMENTALICG 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.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed prostate cancer;
- Able to accept total prostatectomy;
- Patient has given its informed consent.
You may not qualify if:
- Allergic to ICG or iodine;
- High-grade hepatic insufficiency
- refuse attending the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The department of Ultrasound, the third affiliated hospital of Sun Yat-son University
Guangzhou, Guangdong, China
Related Publications (1)
Greco F, Cadeddu JA, Gill IS, Kaouk JH, Remzi M, Thompson RH, van Leeuwen FW, van der Poel HG, Fornara P, Rassweiler J. Current perspectives in the use of molecular imaging to target surgical treatments for genitourinary cancers. Eur Urol. 2014 May;65(5):947-64. doi: 10.1016/j.eururo.2013.07.033. Epub 2013 Aug 7.
PMID: 23957947BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rongqin Zheng RQ Zheng, doctor
Third Affiliated Hospital, Sun Yat-Sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 5, 2016
First Posted
July 21, 2016
Study Start
March 1, 2016
Primary Completion
December 1, 2018
Last Updated
July 21, 2016
Record last verified: 2016-07