Evaluating Positron Emission Mammography Imaging of Suspicious Breast Abnormalities

NCT03520218 | Completed

• 1 other identifier: 18-5029
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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 (millicurie) of F18-Fluorodeoxyglucose (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 Magnetic Resonance Imaging (MRI) and digital breast tomosynthesis (DBT) to study extension of disease and screening of contralateral breast.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Study Arms (1)

Performance of R-PEM

EXPERIMENTAL

5mCi 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

Interventions

Performance of R-PEM DEVICE

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.

Performance of R-PEM

Eligibility Criteria

• Age: 26 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 score 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

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

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• Freitas V, Li X, Scaranelo A, Au F, Kulkarni S, Ghai S, Taeb S, Bubon O, Baldassi B, Komarov B, Parker S, Macsemchuk CA, Waterston M, Olsen KO, Reznik A. Breast Cancer Detection Using a Low-Dose Positron Emission Digital Mammography System. Radiol Imaging Cancer. 2024 Mar;6(2):e230020. doi: 10.1148/rycan.230020.

  PMID: 38334470 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Vivianne Freitas, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 9, 2018
• Study Start: December 17, 2019
• Primary Completion: November 3, 2022
• Study Completion: November 3, 2023
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

CA (1)