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Prostate Cancer Imaging With Radioactive Tracer and Ultrasound Detector Compared to MRI and ProstaScint

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Radiological Associates of Sacramento Medical Group Inc..
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01394042
First Posted: July 14, 2011
Last Update Posted: July 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hybridyne Imaging Technologies
Information provided by:
Radiological Associates of Sacramento Medical Group Inc.
  Purpose
This is a small study to determine if probe, similar to an ultrasound probe, can detect prostate cancer more specifically than other imaging studies in patients with a positive prostate cancer biopsy.

Condition Intervention Phase
Prostate Cancer Device: Proxiscan device Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
Official Title: Exploratory Evaluation of a Transrectal Scintigraphic Detector (Proxiscan) for Detection of Primary Prostate Cancer Utilizing a Radiotracer Targeting Prostate Specific Membrane Antigen (PMSA)

Resource links provided by NLM:


Further study details as provided by Radiological Associates of Sacramento Medical Group Inc.:

Primary Outcome Measures:
  • Detection of PSMA antibody (ProstaScint)uptake patterns measured by Proxiscan in comparison with anatomic biopsy reports, conventional SPECT and MRI scans within one month of Proxiscan [ Time Frame: Within on month of scan and corresponding MRI ]
    Detection of PSMA antibody (ProstaScint) uptake patterns measured by the new transrectal compact gamma camera (Proxiscan) will be compared to the anatomic biopsy reports along with Magnetic Resonance Imaging (MRI) and conventional ProstaScint (Single Photon Emission Computed Tomography) SPECT imaging results. All imaging and biopsy results performed within one month will be used for this investigation


Estimated Enrollment: 12
Study Start Date: June 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No intervention
All consenting patients will be imaged with the Proxiscan and data compared with MRI, ProstaScint and biopsy data
Device: Proxiscan device
All patients will be imaged with the device

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary prostate cancer proven by sextant prostate biopsy
  • Transrectal ultrasound (TRUS)-guided prostate biopsy within 6 months of study enrollment
  • Sufficient time period to complete imaging protocol and 5-7 day safety followup assessment without other therapeutic intervention
  • In the judgement of principal investigator, patient able to provide informed consent and be compliant with protocol requirements
  • ECOG status of 0 or 1 Pt > 18 yrs of age

Exclusion Criteria:

  • Definitive or concomitant therapeutic intervention within the interval of study intervention
  • Prior pelvic therapeutic radiation
  • Active malignancy or therapy for malignancy with 6 months other than basal or squamous cell carcinoma of the skin
  • Pt received radiopharmaceutical which was within 5 half-lives at the time of studying imaging
  • Known history of human-anti-murine-antibodies or known allergic reaction to previously received murine based products
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394042


Locations
United States, California
Roseville PET and Nuclear Imaging Center
Roseville, California, United States, 95661
Sponsors and Collaborators
Radiological Associates of Sacramento Medical Group Inc.
Hybridyne Imaging Technologies
Investigators
Principal Investigator: Benjamin Franc, MD Radiological Associates of Sacramento Medical Group Inc.
  More Information

Responsible Party: Benjamin Franc, MD/PI, RAS
ClinicalTrials.gov Identifier: NCT01394042     History of Changes
Other Study ID Numbers: Proxiscan
First Submitted: July 1, 2011
First Posted: July 14, 2011
Last Update Posted: July 14, 2011
Last Verified: July 2011

Keywords provided by Radiological Associates of Sacramento Medical Group Inc.:
Biopsy proven primary prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases