Evaluating Positron Emission Mammography Imaging of Suspicious Breast Abnormalities

NCT ID: NCT03520218

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-17
• Study Completion Date: 2023-11-03

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Performance of R-PEM

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

Group Type: EXPERIMENTAL

Performance of R-PEM

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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 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

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

• Minimum Eligible Age: 26 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vivianne Freitas, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 38334470 (View on PubMed)

Other Identifiers

18-5029

Identifier Type: -

Identifier Source: org_study_id