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Status unknownNCT01394042Updated Jul 14, 2011

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

An Early Phase 1 interventional study of Proxiscan device in Prostate Cancer, sponsored by Radiological Associates of Sacramento Medical Group Inc.. Status unknown at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-14.

Sponsored by Radiological Associates of Sacramento Medical Group Inc. · Early Phase 1, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jul 2011), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • Biopsy proven primary prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,399 are open to participants now.

This study's planned enrollment of 12 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

This is the only study on the registry with Radiological Associates of Sacramento Medical Group Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Enrollment
12 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceProxiscan device

    All patients will be imaged with the device

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Within on month of scan and corresponding MRI

07

Study locations

1 site
  • Roseville PET and Nuclear Imaging Center
    Roseville, California 95661, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01394042
Lead sponsor
Radiological Associates of Sacramento Medical Group Inc.
Collaborators
Hybridyne Imaging Technologies
First posted
Jul 14, 2011
Start date
Jun 2011
Primary completion
Dec 2011 (estimated)
Completion
Mar 2012 (estimated)
Last update
Jul 14, 2011

Study contacts

Benjamin Franc, MD
principal investigator · Radiological Associates of Sacramento Medical Group Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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