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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Affirm Contrast Biopsy | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Affirm Contrast Biopsy procedure | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 1h (time to complete the procedure) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States | ||
| University of Pittsburgh Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Count of Participants | Participants | Up to 1h (time to complete the procedure) |
|
Up to 1h (time to complete procedure per participant)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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No limitations or caveats were found for this study. A total of 67 subjects were enrolled and seven subjects were withdrawn by the Investigator (did not complete the biopsy procedure), for a final total of 60 subjects who were included in the final analysis. The seven withdrawal cases were not related to any procedure failure but related to no lesion enhancement found or no biopsy needed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Waqas, Director of Global Clinical Affairs | Hologic, Inc. | (508) 826-7183 | ClinicalResearch@Hologic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 11, 2021 | Jul 12, 2023 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
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| D017437 |
| Skin and Connective Tissue Diseases |