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

Sponsor

Radiological Associates of Sacramento Medical Group Inc. (Other)

Overall Status

Unknown status

CT.gov ID

NCT01394042

Collaborator

Hybridyne Imaging Technologies (Other)

Enrollment

Location

Arm

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Device: Proxiscan device	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

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)

Study Start Date :

Jun 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2011

Anticipated Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01394042

Other Study ID Numbers:

Proxiscan

First Posted:

Jul 14, 2011

Last Update Posted:

Jul 14, 2011

Last Verified:

Jul 1, 2011

Keywords provided by , ,

Biopsy proven primary prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Jul 14, 2011