Trial Outcomes & Findings for A Prospective, Multi-site Clinical Study to Collect User Feedback Using Affirm® Contrast Biopsy (NCT NCT04671329)

Results Overview

Technical success was defined as successfully completing the breast biopsy procedure with the Affirm Contrast Biopsy system for each participant (60 participants equals 60 procedures).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

67 participants

Primary outcome timeframe

Up to 1h (time to complete the procedure)

Results posted on

2023-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Affirm Contrast Biopsy Women 40 years of age or older recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities Affirm Contrast Biopsy procedure: Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Selenia Dimensions system and 3Dimensions system. Biopsy targeting can be done on captured contrast enhanced images (scout and stereo pair). The CEDM application shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion. Affirm Contrast Biopsy is intended for patients recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities.
Overall Study STARTED	67
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Affirm Contrast Biopsy n=60 Participants Women 40 years of age or older recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities Affirm Contrast Biopsy procedure: Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Selenia Dimensions system and 3Dimensions system. Biopsy targeting can be done on captured contrast enhanced images (scout and stereo pair). The CEDM application shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion. Affirm Contrast Biopsy is intended for patients recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities.
Age, Continuous	57 years STANDARD_DEVIATION 10 • n=60 Participants
Sex: Female, Male Female	60 Participants n=60 Participants
Sex: Female, Male Male	0 Participants n=60 Participants
Region of Enrollment United States	60 Participants n=60 Participants

PRIMARY outcome

Timeframe: Up to 1h (time to complete the procedure)

Population: Women of 40 years of age or older that were recommended for biopsy who have had a suspicious finding on previous contrast-enhanced imaging or have lesions that may be occult under other modalities.

Technical success was defined as successfully completing the breast biopsy procedure with the Affirm Contrast Biopsy system for each participant (60 participants equals 60 procedures).

Outcome measures

Outcome measures
Measure	Affirm Contrast Biopsy n=60 Participants Women 40 years of age or older recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities Affirm Contrast Biopsy procedure: Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Selenia Dimensions system and 3Dimensions system. Biopsy targeting can be done on captured contrast enhanced images (scout and stereo pair). The CEDM application shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion. Affirm Contrast Biopsy is intended for patients recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities.
Number of Participants With Technical Success	60 Participants

Adverse Events

Affirm Contrast Biopsy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Muhammad Waqas, Director of Global Clinical Affairs

Hologic, Inc.

Phone: (508) 826-7183

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place