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

Stanford University

Status: Withdrawn

Conditions: Kidney Tumor; Bladder Cancer; Prostate Cancer

Treatments: Procedure: photoacoustic imaging; Procedure: robot-assisted laparoscopic surgery; Procedure: fluorescence imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01688414

VAR0083

NCI-2012-01654 (Registry Identifier)

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Diagnostic (fluorescence imaging, PAI)

Experimental group

Description:

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

Treatment:

Procedure: robot-assisted laparoscopic surgery

Procedure: photoacoustic imaging

Procedure: fluorescence imaging