Clinical trial NCT01688414: Imaging During Surgery in Diagnosing Patients With Prostate, Bladder, or Kidney Cancer
Official title: Utility of Fluorescence and Photoacoustic Imaging Intraoperatively to Assist With Robotic Assisted Minimally Invasive Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bladder Cancer
Kidney Tumor
Prostate Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-09-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
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])
timeFrame: Up to 6 months after surgery
measure: Photoacoustic signal intensity (signal-to-noise ratio in the region of interest)
timeFrame: During the time of surgery
measure: Hemoglobin content (lesion total hemoglobin) as determined by photoacoustic measurements
timeFrame: During the time of surgery
measure: Fluorescence intensity (signal-to-noise ratio in the region of interest)
timeFrame: During the time of surgery
measure: Oxygen saturation (percent oxygen saturation in region of interest) as determined by photoacoustic measurements
timeFrame: During the time of surgery
Secondary outcomes:
measure: Subjective operator determined characteristics for ease of identification of pedicle, NV bundle, and lymph nodes (prostate cancer patients)
timeFrame: During the time of surgery
measure: Subjective operator determined characteristics for ease of identification of pedicle, ureter, and lymph nodes (bladder cancer patients)
timeFrame: During the time of surgery
measure: Subjective operator determined characteristics for ease of identification of hilum and tumor (kidney cancer patients)
timeFrame: During the time of surgery
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Mark Gonzalgo
role: PRINCIPAL_INVESTIGATOR
References: