Dose-escalation Study of a Contrast Agent for Delineation of Urological Anatomy in Minimally Invasive Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-26

Study Completion Date

2018-11-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this clinical trial is to study the safety and efficacy of an investigational imaging agent for delineation/visualization of urologic anatomy in the setting of minimally invasive surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Open-label Study to Evaluate Nerindocianine as a Surgical Aid in Ureter Delineation During Minimally Invasive Surgery

NCT04636567

Intraoperative Ureter Injury

WITHDRAWN PHASE2

Intraoperative Gamma Probe Localization of the Ureter

NCT00587548

Abdominal Surgery

TERMINATED NA

Fluorescent Imaging & Methylene Blue: Ureter Study

NCT03177070

Ureteric Injury Surgery Surgery--Complications

COMPLETED PHASE2

Fluorescence Imaging in Finding Tumors in Patients With Kidney Tumors

NCT01281488

Recurrent Renal Cell Cancer Stage I Renal Cell Cancer Stage II Renal Cell Cancer

COMPLETED PHASE1

Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging

NCT01104389

Renal Tumors

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intraoperative Ureter Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Intervention Model

SEQUENTIAL

beginning at the estimated target dose, the dosage was increased and decreased to confirm the near-optimal dose.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nerindocianine for Injection

One Arm: Nerindocianine for Injection (Initial dosing cohort: 0.06 mg/kg body weight); solution, intravenous, one time administration during surgery. the study has only one arm.

Group Type EXPERIMENTAL

Nerindocianine for Injection

Intervention Type DRUG

Procedure: routine minimally invasive pelvic surgery.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nerindocianine for Injection

Procedure: routine minimally invasive pelvic surgery.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

IRDye 800BK

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Provide written informed consent prior to the initiation of study procedures
* Are \> 18 years of age
* Women consented to undergo standard of care minimally invasive pelvic surgery (traditional laparoscopy and robotic surgery)
* Women who are expected to be admitted to the hospital following surgery for at least 24 hours

Exclusion Criteria

* Are unwilling or unable to provide informed consent.
* Are unwilling or unable to comply with the requirements of the protocol.
* History of prior urologic surgery.
* History of prior pelvic surgery.
* History of known retroperitoneal fibrosis.
* Have any of the following screening laboratory values:

* Hemoglobin ≤ 8.0 g/dL;
* Absolute neutrophil count (ANC) ≤ 1500/μL;
* Platelet count ≤ 100,000/μL;
* Serum creatinine ≥ 1.5 x the institutional upper limit of normal (IULN) creatinine;
* Serum bilirubin ≥ 1.5 x IULN;
* Aspartate transaminase (AST or serum glutamic oxaloacetic transaminase, SGOT) ≥ 2x IULN;• Alanine transaminase (ALT or serum glutamate pyruvate transaminase, SGPT) ≥ 2 x IULN.
* Females who are pregnant, lactating, or breastfeeding;
* Any other condition that, in the Investigator's judgment, would potentially compromise the study compliance or the ability to evaluate safety or efficacy.

Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No