The clinical study of evaluation in efficacy and safety using fluorescence imaging with indocyanine green for resected urological cancer - ICG urology

SOGA NORIHITO0 sites35 target enrollmentFebruary 5, 2019

ConditionsRenal cell carcinoma, prostate cancer, bladder cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Renal cell carcinoma, prostate cancer, bladder cancer
Sponsor: SOGA NORIHITO
Enrollment: 35
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The incidence of differences in the success rate between malignant lesions and the parenchyma with open surgery was extremely high but low that with robotic surgery. No case with prostate cancer and bladder cancer was recruited. Since no more case was expected to be recruited, thus this study was decided to quite.

Registry

who.int

Start Date

February 5, 2019

End Date

December 14, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

SOGA NORIHITO

Eligibility Criteria

Inclusion Criteria

•1\. the cases undergoing operation for renal cancer, prostate cancer or bladder cancer, associated with agreement of informed consent for this study, no concerned with clinical staging, historical disease and containing metastasis
•2\. Aged \=\<85 years
•3\.WHO performance status 0 or 1
•4\.Patients who satisfy the following criteria for the major organ function in tests performed within one month prior to enrollment
•WBC \=/under 3000/mm3
•Plt \=/over 100,000/mm3
•Hgb \=/over 8\.0g/mm3
•Ccr \=/over 40ml/m
•T\-Bil \=/under 2\.0mg/dl
•AST \=/under 2\.5xULN

Exclusion Criteria

•1\.allergy for the preparation of iodine or allergy to this study drug
•2\.hepatic and renal dysfunction
•3\.possibility of side effect induced by dysfunction of clearance of ICG or metabolite of ICG
•4\.exclusion decided by physician