MedTrace Logo

Detection and Localization of Carcinoma Using High Resolution Transrectal Imaging - Proof of Concept Study

NCT02786459 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-06-03

No results posted yet for this study

Summary

An exploratory, feasibility and proof-of-concept study to evaluate the capability of a rectal probe scintigraphy device (ProxiScanTM) to detect PSMA specific radiopharmaceutical agent (ProstaScint®; as a surrogate marker for prostate cancer) in patients who have undergone a radical prostatectomy for their disease, patients with multiple negative prostate biopsies and patients with known primary prostate cancer. Developed by Hybridyne Imaging Technologies, Inc. ProxiScanTM is a small cadmium zinc telluride (CST)-based compact gamma camera. It is the same size as a trans-rectal ultrasound (TRUS), currently used for prostate biopsy guidance. Men with multiple positive biopsies will be considered controls. Prostate cancer sextant biopsy histology results will be correlated with ProxiScanTM, TRUS, MRI and SPECT/CT. The investigators hypothesize that it will be safe and feasible to utilize a rectal probe scintigraphy (ProxiScanTM) to detect PSMA specific ProstaScint®, thus identifying and localizing the tumour sites within the prostate and surrounding areas.

Conditions

Interventions

DEVICE

ProxiScan

ProxiScan probe will be coupled with ProstaScint (a radioactive tracer) and used to perform imaging to detect small lesions in the pelvis that will otherwise be hard to detect with conventional imaging modalities.

DEVICE

Magnetic Resonance Imaging

Used as a comparative to ProxiScan.

DEVICE

SPECT-CT

Used as a comparative to ProxiScan.

Sponsors & Collaborators

  • Hybridyne Imaging Technologies Inc

    collaborator UNKNOWN

  • Aytu BioPharma, Inc.

    collaborator INDUSTRY

  • University Health Network, Toronto

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-12-31
Completion
2019-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02786459 on ClinicalTrials.gov