Evaluating Positron Emission Mammography Imaging of Suspicious Breast Abnormalities

Breast Cancer Clinical Trial

Official title:

A Pilot Study to Evaluate Low-Dose Positron Emission Mammography Imaging in Visualization and Characterization of Suspicious Breast Abnormalities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03520218
• Other study ID #: 18-5029
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: September 2021
• Source: University Health Network, Toronto
• Contact: Anabel Scaranelo
• Phone: 416 946-4501
• Email: anabel.scaranelo[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 26 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Congenital Abnormalities

Intervention

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.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre, University Health Network, 610 University Ave.	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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