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


N/A
18 Years
85 Years
Not Enrolling
Both
Bladder Cancer, Kidney Tumor, Prostate Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Margin/lesion status determined by histopathology (cancer status [positive vs negative] as well as grade [Gleason grade 1-5 for prostate cancer, high vs low grade for bladder cancer, and Fuhrman grade 1-4 for kidney cancer])

Outcome Description:

The average lesion signal intensity on PAI and fluorescent imaging will be tested against the histology at pathological examination of the tissue sample.

Outcome Time Frame:

Up to 6 months after surgery

Safety Issue:

No

Principal Investigator

Mark Gonzalgo

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

VAR0083

NCT ID:

NCT01688414

Start Date:

September 2012

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Kidney Tumor
  • Prostate Cancer
  • Urinary Bladder Neoplasms
  • Kidney Neoplasms
  • Prostatic Neoplasms

Name

Location
Stanford University Stanford, California  94305