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Evaluating Positron Emission Mammography Imaging of Suspicious Breast Abnormalities

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ClinicalTrials.gov Identifier: NCT03520218
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : April 5, 2021
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Cancer Device: Performance of R-PEM Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Evaluate Low-Dose Positron Emission Mammography Imaging in Visualization and Characterization of Suspicious Breast Abnormalities
Actual Study Start Date : December 17, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Performance of R-PEM

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

 Device: Performance of R-PEM
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.


Outcome Measures
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Primary Outcome Measures :
  1. Evaluating Performance of the R-PEM system as the Dose Decays [ Time Frame: 2 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   26 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520218


Contacts
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Contact: Anabel Scaranelo 416 946-4501 ext 4833 anabel.scaranelo@uhn.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Centre, University Health Network, 610 University Ave. Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Anabel Scaranelo       Anabel.Scaranelo@uhn.ca   
Principal Investigator: Anabel Scaranelo         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Anabel Scaranelo University Health Network, Toronto
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03520218    
Other Study ID Numbers: 18-5029
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Congenital Abnormalities