Prostate Cancer Clinical Trial
Official title:
A Pilot and Feasibility Study of Indocyanine Green-based Fluorescence Imaging in Localization of Prostate Cancer and Metastatic Lymph Nodes
NCT number | NCT02840617 |
Other study ID # | sysu160511 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 1 |
First received | July 5, 2016 |
Last updated | July 18, 2016 |
Start date | March 2016 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
China | The department of Ultrasound, the third affiliated hospital of Sun Yat-son University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Third Affiliated Hospital, Sun Yat-Sen University |
China,
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. Review. Erratum in: Eur Urol. 2015 Mar;67(3):e64. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | sensitivity and specificity of the ICG-based fluorescence imaging to detect metastatic lymph nodes | sensitivity (true positive) and specificity (true negative) of the ICG-based fluorescence to detect metastatic lymph nodes in vivo and in vitro compared to histological analysis | 1 week post-surgery | No |
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