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

Primary Purpose

Bladder Cancer, Kidney Tumor, Prostate Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
photoacoustic imaging
fluorescence imaging
robot-assisted laparoscopic surgery
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bladder Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Diagnostic (fluorescence imaging, PAI)

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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])
    The average lesion signal intensity on PAI and fluorescent imaging will be tested against the histology at pathological examination of the tissue sample.
    Photoacoustic signal intensity (signal-to-noise ratio in the region of interest)
    The average lesion signal intensity on PAI and fluorescent imaging will be tested against the histology at pathological examination of the tissue sample. The distribution of signal intensity on PAI will be graphed as boxplot. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.
    Hemoglobin content (lesion total hemoglobin) as determined by photoacoustic measurements
    The distribution of signal intensity on hemoglobin content will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.
    Fluorescence intensity (signal-to-noise ratio in the region of interest)
    The distribution of signal intensity on fluorescence intensity will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.
    Oxygen saturation (percent oxygen saturation in region of interest) as determined by photoacoustic measurements
    The distribution of signal intensity on oxygen saturation will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.

    Secondary Outcome Measures

    Subjective operator determined characteristics for ease of identification of pedicle, NV bundle, and lymph nodes (prostate cancer patients)
    Descriptive statistics will be used to describe the operator determined secondary endpoints of the utility of each different imaging modality (i.e. white light, PAI, and fluorescence imaging).
    Subjective operator determined characteristics for ease of identification of pedicle, ureter, and lymph nodes (bladder cancer patients)
    Descriptive statistics will be used to describe the operator determined secondary endpoints of the utility of each different imaging modality (i.e. white light, PAI, and fluorescence imaging).
    Subjective operator determined characteristics for ease of identification of hilum and tumor (kidney cancer patients)
    Descriptive statistics will be used to describe the operator determined secondary endpoints of the utility of each different imaging modality (i.e. white light, PAI, and fluorescence imaging).

    Full Information

    First Posted
    September 12, 2012
    Last Updated
    July 25, 2014
    Sponsor
    Stanford University
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01688414
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI left Stanford
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    September 2015 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Stanford University
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bladder Cancer, Kidney Tumor, Prostate Cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diagnostic (fluorescence imaging, PAI)
    Arm Type
    Experimental
    Arm Description
    Patients undergo fluorescence imaging and PAI during robot assisted laparoscopic surgery.
    Intervention Type
    Procedure
    Intervention Name(s)
    photoacoustic imaging
    Other Intervention Name(s)
    optoacoustic imaging, PAI
    Intervention Description
    Undergo PAI
    Intervention Type
    Procedure
    Intervention Name(s)
    fluorescence imaging
    Intervention Description
    Undergo fluorescence imaging
    Intervention Type
    Procedure
    Intervention Name(s)
    robot-assisted laparoscopic surgery
    Intervention Description
    Undergo robot-assisted laparoscopic surgery
    Primary Outcome Measure Information:
    Title
    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])
    Description
    The average lesion signal intensity on PAI and fluorescent imaging will be tested against the histology at pathological examination of the tissue sample.
    Time Frame
    Up to 6 months after surgery
    Title
    Photoacoustic signal intensity (signal-to-noise ratio in the region of interest)
    Description
    The average lesion signal intensity on PAI and fluorescent imaging will be tested against the histology at pathological examination of the tissue sample. The distribution of signal intensity on PAI will be graphed as boxplot. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.
    Time Frame
    During the time of surgery
    Title
    Hemoglobin content (lesion total hemoglobin) as determined by photoacoustic measurements
    Description
    The distribution of signal intensity on hemoglobin content will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.
    Time Frame
    During the time of surgery
    Title
    Fluorescence intensity (signal-to-noise ratio in the region of interest)
    Description
    The distribution of signal intensity on fluorescence intensity will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.
    Time Frame
    During the time of surgery
    Title
    Oxygen saturation (percent oxygen saturation in region of interest) as determined by photoacoustic measurements
    Description
    The distribution of signal intensity on oxygen saturation will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.
    Time Frame
    During the time of surgery
    Secondary Outcome Measure Information:
    Title
    Subjective operator determined characteristics for ease of identification of pedicle, NV bundle, and lymph nodes (prostate cancer patients)
    Description
    Descriptive statistics will be used to describe the operator determined secondary endpoints of the utility of each different imaging modality (i.e. white light, PAI, and fluorescence imaging).
    Time Frame
    During the time of surgery
    Title
    Subjective operator determined characteristics for ease of identification of pedicle, ureter, and lymph nodes (bladder cancer patients)
    Description
    Descriptive statistics will be used to describe the operator determined secondary endpoints of the utility of each different imaging modality (i.e. white light, PAI, and fluorescence imaging).
    Time Frame
    During the time of surgery
    Title
    Subjective operator determined characteristics for ease of identification of hilum and tumor (kidney cancer patients)
    Description
    Descriptive statistics will be used to describe the operator determined secondary endpoints of the utility of each different imaging modality (i.e. white light, PAI, and fluorescence imaging).
    Time Frame
    During the time of surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark Gonzalgo
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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