Suspended

Utility of Fluorescence and Photoacoustic Imaging Intraoperatively to Assist With Robotic Assisted Minimally Invasive Surgery

What is being tested

photoacoustic imaging

+ fluorescence imaging

+ robot-assisted laparoscopic surgery

Procedure

Who is being recruted

Urogenital Diseases+20

+ Genital Diseases

+ Adenocarcinoma

From 18 to 85 Years

+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Diagnostic Study

Interventional

Study Start: September 2012

See protocol details

Summary

Principal SponsorStanford University

Last updated: July 29, 2014

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVES: I. The primary objective of this pilot study is to assess the ability of fluorescent imaging and photoacoustic imaging (PAI) in a clinical setting to distinguish benign from malignant tissue. SECONDARY OBJECTIVES: I. To qualitatively determine the possible benefit of PAI and fluorescent imaging over traditional white light imaging. OUTLINE: Patients undergo fluorescence imaging and PAI during robot assisted laparoscopic surgery.

NCT01688414

Principal SponsorStanford University

Last updated: July 29, 2014

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdenocarcinomaUrinary Bladder DiseasesCarcinomaFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, MaleGenital Neoplasms, MaleKidney DiseasesKidney NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialProstatic DiseasesUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsFemale Urogenital DiseasesMale Urogenital DiseasesUrinary Bladder NeoplasmsCarcinoma, Renal CellProstatic Neoplasms

Criteria

2 inclusion criteria required to participate

Ability to understand and the willingness to sign a written informed consent document

Patients must have a pathologic confirmation of prostate cancer, bladder cancer, or kidney cancer based on previous biopsies or procedures OR a strong concern for a kidney malignancy based on computed tomography (CT) or magnetic resonance imaging (MRI) imaging

3 exclusion criteria prevent from participating

Patients with a surgical history or anatomic variant that would preclude robot assisted laparoscopic approaches to their surgery (i.e. history of ventral hernia repair with mesh)

Patients with documented allergy or adverse drug reaction to indocyanine green or baseline serum creatinine greater than 1.5 mg/dL

Patients with medical co-morbidities who cannot tolerate laparoscopic surgery secondary to intra-abdominal carbon dioxide insufflation

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Patients undergo fluorescence imaging and PAI during robot assisted laparoscopic surgery.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

SuspendedNo study centers