search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Proxiscan device
Sponsored by
Radiological Associates of Sacramento Medical Group Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Biopsy proven primary prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Roseville PET and Nuclear Imaging Center

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

No intervention

Arm Description

All consenting patients will be imaged with the Proxiscan and data compared with MRI, ProstaScint and biopsy data

Outcomes

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
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

Secondary Outcome Measures

Full Information

First Posted
July 1, 2011
Last Updated
July 12, 2011
Sponsor
Radiological Associates of Sacramento Medical Group Inc.
Collaborators
Hybridyne Imaging Technologies
search

1. Study Identification

Unique Protocol Identification Number
NCT01394042
Brief Title
Prostate Cancer Imaging With Radioactive Tracer and Ultrasound Detector Compared to MRI and ProstaScint
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Radiological Associates of Sacramento Medical Group Inc.
Collaborators
Hybridyne Imaging Technologies

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Biopsy proven primary prostate cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No intervention
Arm Type
No Intervention
Arm Description
All consenting patients will be imaged with the Proxiscan and data compared with MRI, ProstaScint and biopsy data
Intervention Type
Device
Intervention Name(s)
Proxiscan device
Intervention Description
All patients will be imaged with the device
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
Within on month of scan and corresponding MRI

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Franc, MD
Organizational Affiliation
Radiological Associates of Sacramento Medical Group Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roseville PET and Nuclear Imaging Center
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs