Breast CancerNCT04671329

A Prospective, Multi-site Clinical Study to Collect User Feedback Using Affirm® Contrast Biopsy

A study testing Affirm Contrast Biopsy procedure in people with Breast Cancer, run by Hologic, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Cancer
What is being tested?: Affirm Contrast Biopsy procedure
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 2 sitesUnited States
Study dates: 5 Mar 2021to 18 Aug 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Mayo Clinic
Phoenix, Arizona, 85054
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Conditions: Breast Cancer
Being tested: Affirm Contrast Biopsy procedure
Keywords: Breast Biopsy, Contrast Biopsy
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Affirm Contrast Biopsy procedureDevice
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.

Study groups in NCT04671329
Study group	Role	What they receive
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 Receives: Device: Affirm Contrast Biopsy procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Up to 1h (time to complete the procedure)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Mar 202118 Aug 2022

First posted17 Dec 2020
Study start5 Mar 2021
Primary completion18 Apr 2022
Study completion18 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04671329
Sponsor's protocol ID: 20-03
Status last verified: Oct 2023
First submitted: 1 Dec 2020
Last updated: 16 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-site Clinical Study to Collect User Feedback Using Affirm® Contrast Biopsy
ClinicalTrials.gov ID: NCT04671329
Acronym / sponsor ID: 20-03
Conditions: Breast Cancer
Keywords: Breast Biopsy, Contrast Biopsy
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Hologic, Inc.Industry (pharma, biotech, devices)
Study start: 5 Mar 2021 (actual)
Primary completion: 18 Apr 2022 (actual)
Study completion: 18 Aug 2022 (actual)
First posted: 17 Dec 2020 (actual)
Results: Posted 5 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Affirm Contrast Biopsy	Other	Device: Affirm Contrast Biopsy procedureWomen 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

Who may qualify

Ages: 40 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Affirm Contrast Biopsy procedureContrast 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.	Device	Affirm Contrast Biopsy

Primary outcome

Number of Participants With Technical Success
Time frame: 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).

Results and safety

Results posted to the registry on 5 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Affirm Contrast Biopsy	67	60

Primary outcome: Number of Participants With Technical Success

Time frame: Up to 1h (time to complete the procedure). Count of participants. Unit: Participants

Measure	Affirm Contrast Biopsy n = 60
Value	60

Population analysed: 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.

Adverse events

Time frame: Up to 1h (time to complete procedure per participant). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Affirm Contrast Biopsy	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Active, not recruitingPhase 1/2
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Not yet recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Affirm Contrast Biopsy procedure in people with Breast Cancer, run by Hologic, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Technical Success (time frame: Up to 1h (time to complete the procedure)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04671329.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.