Imaging During Surgery in Diagnosing Patients With Prostate, Bladder, or Kidney Cancer

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

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Brief Summary

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This pilot clinical trial studies imaging during surgery in diagnosing patients with prostate, bladder, or kidney cancer. New diagnostic imaging procedures, may find prostate, bladder, or kidney cancer

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Detailed Description

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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.

Conditions

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Bladder Cancer Kidney Tumor Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (fluorescence imaging, PAI)

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

Group Type EXPERIMENTAL

photoacoustic imaging

Intervention Type PROCEDURE

Undergo PAI

fluorescence imaging

Intervention Type PROCEDURE

Undergo fluorescence imaging

robot-assisted laparoscopic surgery

Intervention Type PROCEDURE

Undergo robot-assisted laparoscopic surgery

Interventions

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photoacoustic imaging

Undergo PAI

Intervention Type PROCEDURE

fluorescence imaging

Undergo fluorescence imaging

Intervention Type PROCEDURE

robot-assisted laparoscopic surgery

Undergo robot-assisted laparoscopic surgery

Intervention Type PROCEDURE

Other Intervention Names

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optoacoustic imaging PAI

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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 medical co-morbidities who cannot tolerate laparoscopic surgery secondary to intra-abdominal carbon dioxide insufflation
* Patients with documented allergy or adverse drug reaction to indocyanine green or baseline serum creatinine greater than 1.5 mg/dL

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No