Trial Outcomes & Findings for Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer (NCT NCT01303419)

Results Overview

Subjects have completed both CE-BMRI and DE-CEDM scan types

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

224 participants

Primary outcome timeframe

Approximately 8 weeks

Results posted on

2019-04-10

Participant Flow

Women 21 years of age or older, with newly diagnosed cancer identified through through core biopsy or fine-needle aspiration (FNA) within the last 30 days and with a bilateral CE-BMRI performed within 30 days of the new breast cancer diagnosis.

Participant milestones

Participant milestones
Measure	CE-BMRI and DE-CEDM Examinations Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam. CE-BMRI: Contrast-enhanced breast imaging using Magnetic Resonance DE-CEDM: Breast imaging using Dual-energy, contrast-enhanced digital mammography
Overall Study STARTED	224
Overall Study COMPLETED	128
Overall Study NOT COMPLETED	96

Reasons for withdrawal

Reasons for withdrawal
Measure	CE-BMRI and DE-CEDM Examinations Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam. CE-BMRI: Contrast-enhanced breast imaging using Magnetic Resonance DE-CEDM: Breast imaging using Dual-energy, contrast-enhanced digital mammography
Overall Study Discontinuation of study	60
Overall Study Did not complete both imaging methods	5
Overall Study Did not meet all I/E after screening	31

Baseline Characteristics

Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CE-BMRI and DE-CEDM Examinations n=224 Participants Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam. CE-BMRI: Contrast-enhanced breast imaging using Magnetic Resonance DE-CEDM: Breast imaging using Dual-energy, contrast-enhanced digital mammography
Age, Customized Subjects age 21 years or older	224 Participants n=5 Participants
Sex: Female, Male Female	224 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Canada	5 participants n=5 Participants
Region of Enrollment Belgium	29 participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants
Region of Enrollment France	59 participants n=5 Participants
Region of Enrollment Germany	118 participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 8 weeks

Population: Total number of participants enrolled in the study

Subjects have completed both CE-BMRI and DE-CEDM scan types

Outcome measures

Outcome measures
Measure	CE-BMRI and DE-CEDM Examinations n=224 Participants Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam. CE-BMRI: Contrast-enhanced breast imaging using Magnetic Resonance DE-CEDM: Breast imaging using Dual-energy, contrast-enhanced digital mammography
Completion of CE-BMRI and DE-CEDM Subjects did not complete both scan typess	96 Participants
Completion of CE-BMRI and DE-CEDM Subjects completing both scan types	128 Participants

PRIMARY outcome

Timeframe: Within 1 week of CE-BMRI scan

Population: All subjects who completed both CE-BMRI and DE-CEDM examinations

Average maximum lesion size when scanned using CE-BMRI

Outcome measures

Outcome measures
Measure	CE-BMRI and DE-CEDM Examinations n=128 Participants Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam. CE-BMRI: Contrast-enhanced breast imaging using Magnetic Resonance DE-CEDM: Breast imaging using Dual-energy, contrast-enhanced digital mammography
Average Maximum Lesion Size by CE-BMRI Scan	28.8 millimeters (mm) Interval 6.0 to 110.0

PRIMARY outcome

Timeframe: Within 1 week of DE-CEDM scan

Population: All subjects who completed both CE-BMRI and DE-CEDM examinations

Average maximum lesion size when scanned using DE-CEDM

Outcome measures

Outcome measures
Measure	CE-BMRI and DE-CEDM Examinations n=128 Participants Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam. CE-BMRI: Contrast-enhanced breast imaging using Magnetic Resonance DE-CEDM: Breast imaging using Dual-energy, contrast-enhanced digital mammography
Average Maximum Lesion Size by DE-CEDM	30.5 millimeters (mm) Interval 5.0 to 150.0

PRIMARY outcome

Timeframe: Approximately 1 week; upon completion of histology report

Population: Subjects who underwent CE-BMRI and DE-CEDM

Average maximum lesion size as described in histology report.

Outcome measures

Outcome measures
Measure	CE-BMRI and DE-CEDM Examinations n=128 Participants Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam. CE-BMRI: Contrast-enhanced breast imaging using Magnetic Resonance DE-CEDM: Breast imaging using Dual-energy, contrast-enhanced digital mammography
Average Maximum Lesion Size by Histology Outcome	28.2 millimeters (mm) Interval 4.0 to 169.0

PRIMARY outcome

Timeframe: This outcome did not occur due to premature study stop.

Population: Study was prematurely stopped.

Multi-reader evaluation of images and comparison between CE-BMRI vs. DE-CEDM to determine which technology can more precisely measure cancer size as determined by pathological examination was planned. This was not conducted due to premature stop of the study.

Outcome measures

Outcome data not reported

Adverse Events

CE-BMRI and DE-CEDM Examinations

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CE-BMRI and DE-CEDM Examinations n=224 participants at risk Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam. CE-BMRI: Contrast-enhanced breast imaging using Magnetic Resonance DE-CEDM: Breast imaging using Dual-energy, contrast-enhanced digital mammography
Gastrointestinal disorders Abdominal pain	0.45% 1/224 • Number of events 1 • Duration of scan - approximately 1 hour
General disorders extravasation	1.8% 4/224 • Number of events 4 • Duration of scan - approximately 1 hour
Immune system disorders Allergy to contrast media	0.45% 1/224 • Number of events 1 • Duration of scan - approximately 1 hour
Nervous system disorders Presyncope	0.89% 2/224 • Number of events 2 • Duration of scan - approximately 1 hour
Psychiatric disorders Panic attack	0.45% 1/224 • Number of events 1 • Duration of scan - approximately 1 hour

Additional Information

Jean-Paul Antonini

GE Healthcare

Phone: +33 130709703

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place