ICG urology

JRCT ID: jRCTs041180038

Registered date:05/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Renal cell carcinoma, prostate cancer, bladder cancer
• Date of first enrollment: 15/05/2014
• Target sample size: 150
• Study type: Interventional
• Intervention(s): fluorescence imaging with indocyanine green

Outcome(s)

• Primary Outcome: Efficacy of color contrast detect the lymphoid flow
• Secondary Outcome: safety

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 85age old
• Gender: Both

Include 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
ALT =/under 2.5xULN

Exclude 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

Related Information

• Primary Sponsor: SOGA NORIHITO