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Evaluating Positron Emission Mammography Imaging of Suspicious Breast Abnormalities

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Performance of R-PEM
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

26 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is female of any race and ethnicity
  • Subject is at least 26 years old
  • Following routine mammography imaging, subject is categorized as BI-RADS® 4C or 5 because of calcifications, masses, asymmetries or/and architectural distortion will undergo additional tests including biopsy within 30 days of routine imaging
  • Subject is female with a recent breast biopsy confirming breast cancer

Exclusion Criteria:

  • Subject unable or unwilling to undergo informed consent
  • Subjects who are unable or unwilling to tolerate any of the imaging tests because of claustrophobia, compression, etc.
  • Subjects who are pregnant or who think they may be pregnant
  • Subjects who are breast-feeding
  • Subjects weight exceed table limits of MRI and PET-CT (300-450 lb or 135-205 kg)
  • Subjects with history of allergic reaction to gadolinium or previous history of life-threatening anaphylactic reaction to any contrast.
  • Claustrophobic subjects

Sites / Locations

  • Princess Margaret Cancer Centre, University Health Network, 610 University Ave.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Performance of R-PEM

Arm Description

5miCi of F-18 FDG will be injected and patients will wait for uptake of FDG before proceeding with first set of R-PEM scans. Additional optional R-PEM scans may be performed 4 hours after injection, and then possibly 7 hours after injection. These R-PEM images will be compared to standard diagnostic breast work-up using DBT and MRI

Outcomes

Primary Outcome Measures

Evaluating Performance of the R-PEM system as the Dose Decays
The diagnostic performance of R-PEM including sensitivity, specificity, positive and negative predictive values compared to magnetic resonance imaging, digital breast tomosynthesis mammography, and digital mammography in characterization of suspicious breast abnormalities will also be evaluated in our study when those images are available through standard patient care.

Secondary Outcome Measures

Full Information

First Posted
April 27, 2018
Last Updated
September 29, 2021
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03520218
Brief Title
Evaluating Positron Emission Mammography Imaging of Suspicious Breast Abnormalities
Official Title
A Pilot Study to Evaluate Low-Dose Positron Emission Mammography Imaging in Visualization and Characterization of Suspicious Breast Abnormalities
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 17, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this pilot project is to test the new Radialis Positron Emission Mammography (R-PEM) system in breast cancer patients that has a higher sensitivity with lower radiation doses than conventional PET/CT. The plan for the pilot study is to image patients who are already scheduled for diagnostic imaging for breast cancer after a positive core biopsy. Participants will be injected with 5mCi of F-18 FDG and patient will wait for a couple of hours for uptake of FDG. After this time, the first R-PEM scan will occur. Additional optional R-PEM scans can be performed 4 hours after injection and 7 hours after injection with reductions in radiation emission. Additionally, R-PEM images will be compared to standard-of-care breast MRI and digital breast tomosynthesis to study extension of disease and screening of contralateral breast.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Performance of R-PEM
Arm Type
Experimental
Arm Description
5miCi of F-18 FDG will be injected and patients will wait for uptake of FDG before proceeding with first set of R-PEM scans. Additional optional R-PEM scans may be performed 4 hours after injection, and then possibly 7 hours after injection. These R-PEM images will be compared to standard diagnostic breast work-up using DBT and MRI
Intervention Type
Device
Intervention Name(s)
Performance of R-PEM
Intervention Description
R-PEM imaging will produce high-sensitivity images with low levels of F-18 FDG and optional subsequent scans performed will display reduced levels of the injected radiotracer.
Primary Outcome Measure Information:
Title
Evaluating Performance of the R-PEM system as the Dose Decays
Description
The diagnostic performance of R-PEM including sensitivity, specificity, positive and negative predictive values compared to magnetic resonance imaging, digital breast tomosynthesis mammography, and digital mammography in characterization of suspicious breast abnormalities will also be evaluated in our study when those images are available through standard patient care.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is female of any race and ethnicity Subject is at least 26 years old Following routine mammography imaging, subject is categorized as BI-RADS® 4C or 5 because of calcifications, masses, asymmetries or/and architectural distortion will undergo additional tests including biopsy within 30 days of routine imaging Subject is female with a recent breast biopsy confirming breast cancer Exclusion Criteria: Subject unable or unwilling to undergo informed consent Subjects who are unable or unwilling to tolerate any of the imaging tests because of claustrophobia, compression, etc. Subjects who are pregnant or who think they may be pregnant Subjects who are breast-feeding Subjects weight exceed table limits of MRI and PET-CT (300-450 lb or 135-205 kg) Subjects with history of allergic reaction to gadolinium or previous history of life-threatening anaphylactic reaction to any contrast. Claustrophobic subjects
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anabel Scaranelo
Phone
416 946-4501
Ext
4833
Email
anabel.scaranelo@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anabel Scaranelo
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Cancer Centre, University Health Network, 610 University Ave.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anabel Scaranelo
Email
Anabel.Scaranelo@uhn.ca
First Name & Middle Initial & Last Name & Degree
Anabel Scaranelo

12. IPD Sharing Statement

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Evaluating Positron Emission Mammography Imaging of Suspicious Breast Abnormalities

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