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

NCT ID: NCT01394042

Last Updated: 2011-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Study Groups

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No intervention

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

Group Type NO_INTERVENTION

Proxiscan device

Intervention Type DEVICE

All patients will be imaged with the device

Interventions

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Proxiscan device

All patients will be imaged with the device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hybridyne Imaging Technologies

UNKNOWN

Sponsor Role collaborator

Radiological Associates of Sacramento Medical Group Inc.

OTHER

Sponsor Role lead

Responsible Party

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RAS

Principal Investigators

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Benjamin Franc, MD

Role: PRINCIPAL_INVESTIGATOR

Radiological Associates of Sacramento Medical Group Inc.

Locations

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Roseville PET and Nuclear Imaging Center

Roseville, California, United States

Site Status

Countries

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United States

Other Identifiers

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Proxiscan

Identifier Type: -

Identifier Source: org_study_id

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