Prostate Cancer
Conditions
Keywords
ICG, prostate cancer
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.
Interventions
DRUGIndocyanine Green (ICG)
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sensitivity and specificity of the ICG-based fluorescence to detect prostate cancer | 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
| Measure | Time frame | Description |
|---|---|---|
| sensitivity and specificity of the ICG-based fluorescence imaging to detect metastatic lymph nodes | 1 week post-surgery | 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 |
Countries
China
Contacts
Primary ContactRongqin Zheng RQ Zheng, doctor
Backup ContactHuichao Zhou HC Zhou, doctor
Outcome results
None listed