Breast Cancer
Conditions
Keywords
Breast Biopsy, Contrast Biopsy
Brief summary
Currently, if a radiologist finds a suspicious lesion seen only on a diagnostic Contrast Enhanced Digital Mammography (CEDM) exam requiring biopsy the biopsy procedure would likely be performed with MRI guidance because there are currently limited solutions to biopsy with CEDM guidance. Affirm Contrast Biopsy will provide an additional solution to biopsy/localize lesions found by using a CEDM imaging modality.
Interventions
DEVICEAffirm 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.
Sponsors
Hologic, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Females aged 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 * Subject is able to read, understand, and sign the study specific informed consent form after the nature of the study has been fully explained to them
Exclusion criteria
* Subjects who require a Legally Authorized Representative (LAR) for Informed Consent * Subjects who, based on the physician's judgement, may be at increased risk for complications associated with renal function, anticoagulant therapy, or bleeding disorders * Subjects who have had a previous allergic reaction to IV contrast agent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Technical Success | Up to 1h (time to complete the procedure) | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Affirm Contrast Biopsy | — |
|---|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 10 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 60 Participants | — |
| Sex: Female, Male Female | 60 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Number of Participants With Technical Success
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).
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Affirm Contrast Biopsy | Number of Participants With Technical Success | 60 Participants |