Symptomatic Breast LumpNCT02762565

Clinical Utility of a Low-Cost Hand-Held Breast Scanner

A study testing PEFS system (Product Name: Intelligent Breast Exam™ or iBE™ in people with Symptomatic Breast Lump, run by Abramson Cancer Center at Penn Medicine at 1 site 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

Early detection of breast cancer improves the survival rate and makes treatment less costly. This study would measure the accuracy a low-cost hand-held commercially viable device, iBE, for the detection of clinically relevant findings in the breast using the results of current mammography as a comparison. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Symptomatic Breast Lump
What is being tested?: PEFS system (Product Name: Intelligent Breast Exam™ or iBE™
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 89 participants
Where: 1 siteUnited States
Study dates: Feb 2015to Dec 2016
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 years of age and older
Women and men with symptomatic breast lump (either by palpation or imaging) OR
Asymptomatic women presenting to the imaging center for a screening mammogram.
Signed Informed Consent

Who cannot join

Patients under 18 years of age
Patients who previously participated in this study and are returning to the Women's Imaging Center for follow-up diagnostic tests

Trial locations and contacts

1 site in 1 country.

United States1 site

Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Conditions: Symptomatic Breast Lump
Being tested: PEFS system (Product Name: Intelligent Breast Exam™ or iBE™

What participants receive

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

PEFS system (Product Name: Intelligent Breast Exam™ or iBE™Device

Study groups in NCT02762565
Study group	Role	What they receive
breast scanner	Experimental	Not described Receives: Device: PEFS system (Product Name: Intelligent Breast Exam™ or iBE™

What is being measured

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

Number of Quadrants With Detected Breast Lesions
The iBE results were evaluated by definitive quadrants. The definitive quadrants break down the superimposed clock into 4 equal sectors (e.g. 12-3, 3-6, 6-9, 9-12).
Measured: 3 months
Sensitivity of iBE Breast Lesion Detection
the number of quadrants with positive breast lesion detected by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant. 77 quadrants were labeled positive for breast lesion by iBE, 66 were confirmed positive by mammogram or ultrasound allowing calculation of sensitivity of the the iBE breast lesion detection
Measured: 1 day
Specificity of iBE Breast Lesion Detection
the number of quadrants characterized normal breast by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant
Measured: 1 day

Timeline

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

Feb 2015Dec 2016

First posted5 May 2016 (estimated)
Study startFeb 2015
Primary completionJan 2016
Study completionDec 2016

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 Symptomatic Breast LumpStudies of the same condition, open and under way.
More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
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
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02762565
Sponsor's protocol ID: UPCC 24114
Status last verified: May 2021
First submitted: 25 Apr 2016
Last updated: 16 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Utility of a Low-Cost Hand-Held Breast Scanner
ClinicalTrials.gov ID: NCT02762565
Acronym / sponsor ID: UPCC 24114
Conditions: Symptomatic Breast Lump
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Abramson Cancer Center at Penn MedicineUniversity, hospital or other
Study start: Feb 2015 (actual)
Primary completion: Jan 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 5 May 2016 (estimated)
Results: Posted 29 Apr 2021

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
Number of arms: 1

Arm	Type	Receives
breast scanner	Experimental	Device: PEFS system (Product Name: Intelligent Breast Exam™ or iBE™

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

18 years of age and older
Women and men with symptomatic breast lump (either by palpation or imaging) OR
Asymptomatic women presenting to the imaging center for a screening mammogram.
Signed Informed Consent

Key exclusion criteria (2 listed)

Patients under 18 years of age
Patients who previously participated in this study and are returning to the Women's Imaging Center for follow-up diagnostic tests

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
PEFS system (Product Name: Intelligent Breast Exam™ or iBE™	Device	breast scanner

Primary outcome

Number of Quadrants With Detected Breast Lesions
Time frame: 3 months
The iBE results were evaluated by definitive quadrants. The definitive quadrants break down the superimposed clock into 4 equal sectors (e.g. 12-3, 3-6, 6-9, 9-12).
Sensitivity of iBE Breast Lesion Detection
Time frame: 1 day
the number of quadrants with positive breast lesion detected by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant. 77 quadrants were labeled positive for breast lesion by iBE, 66 were confirmed positive by mammogram or ultrasound allowing calculation of sensitivity of the the iBE breast lesion detection
Specificity of iBE Breast Lesion Detection
Time frame: 1 day
the number of quadrants characterized normal breast by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant

Results and safety

Results posted to the registry on 29 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Breast Scanner	89	78

Primary outcome: Number of Quadrants With Detected Breast Lesions

Time frame: 3 months. Count of units. Unit: quadrants

Measure	Breast Scanner n = 78
Number of quadrants positive for a lesion	77
Number of quadrants negative for a lesion	265

Population analysed: the iBE result of each participant was broken into 4 quadrants for each breast. Some quadrants were missing iBE data. 78 participants and 342 quadrants, 77 is the number of quadrants with positive findings of the 78 participants and the 342 quadrants analyzed.

Primary outcome: Sensitivity of iBE Breast Lesion Detection

Time frame: 1 day. Count of units. Unit: quadrants

Measure	Breast Scanner n = 78
Value	66

Population analysed: quadrants with positive breast lesions

Primary outcome: Specificity of iBE Breast Lesion Detection

Time frame: 1 day. Count of units. Unit: quadrants

Measure	Breast Scanner n = 78
Value	237

Population analysed: breast quadrants negative for breast lesions

Adverse events

Time frame: 1 week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Breast Scanner	0 of 78 (0%)	0 of 78 (0%)	0 of 78

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Ari Brooks, MD principal investigator

Abramson Cancer Center at Penn Medicine

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

Questions about this trial

What is this clinical trial studying?

A study testing PEFS system (Product Name: Intelligent Breast Exam™ or iBE™ in people with Symptomatic Breast Lump, run by Abramson Cancer Center at Penn Medicine at 1 site 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 4 inclusion and 2 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 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 29 Apr 2021). 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 Quadrants With Detected Breast Lesions (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT02762565.

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 Aug 2021.