Breast CancerNCT04815291

Streamlined Localization Using SCOUT® at Biopsy (STREAMLoc )

A study testing Receives SCOUT at biopsy in people with Breast Cancer, run by Merit Medical Systems, Inc. at 2 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years, women only
Conditions the study is for: Breast Cancer
What is being tested?: Receives SCOUT at biopsy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 93 participants
Where: 2 sitesCanada
Study dates: 1 Apr 2022to 15 Jan 2024
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 to 80 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Woman >18 years and < 80 years of age;
Classified as Breast Imaging Reporting and Data System (BI-RADS) 4C or 5;
Lesion depth is < 6 cm from skin surface;
Non-palpable lesions;
Informed consent obtained.

Who cannot join

Multicentric breast cancer;
Pregnant or lactating;
Known or suspected nickel-titanium allergy.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec
St. Sacrement
Québec

Other trials in Canada

About this study

Official title: STREAMLoc- Streamlined Localization Using SCOUT® at Biopsy: An Analysis of Process Improvement, Cost Savings and Enhanced Patient Experience.

This registry is intended to demonstrate the utility of SCOUT® in the Canadian public and US healthcare systems with fixed resources and a conservative approach to patient and clinician exposure to harm. The efficacy and safety of this system will be further assessed, as well as the acceptance of clinicians and patients.

Read the detailed description

This registry is intended to demonstrate the utility of SCOUT® in the Canadian public and US healthcare systems with fixed resources and a conservative approach to patient and clinician exposure to harm (i.e., radiation, COVID-19 exposure, patient emotional trauma). By assessing the utility of reflector insertion at the time of biopsy, this study will be able to measure the impact on patient visits to the breast center for invasive procedures between biopsy and surgery, and quantify this value to the public healthcare system. The efficacy and safety of this system will be further assessed, as well as the acceptance of clinicians and patients.

Conditions: Breast Cancer
Being tested: Receives SCOUT at 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.

Receives SCOUT at biopsyDevice
SCOUT Reflector

Study groups in NCT04815291
Study group	Role	What they receive
Device	Experimental	Receives SCOUT at biopsy Receives: Device: Receives SCOUT at biopsy

What is being measured

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

Number of Participants Invasive Visits
Number of visits to the breast centre for an invasive procedure between biopsy and surgery
Measured: through study completion, an average of 6 months

Secondary outcomes (2)

Number of Participants With Adverse Events
Device-related adverse event rate
Measured: through study completion; an average of 6 months
Performance
Successful Procedure is absence of close margins (<2mm), positive margins (tumor on ink) or requirement for re-excision.
Measured: through study completion; an average of 6 months

Timeline

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

1 Apr 202215 Jan 2024

First posted25 Mar 2021
Study start1 Apr 2022
Primary completion15 Jan 2024
Study completion15 Jan 2024

Why it stopped: Sponsor decision.

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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04815291
Sponsor's protocol ID: SCOUT2021
Status last verified: May 2024
First submitted: 16 Mar 2021
Last updated: 21 May 2024
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 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: STREAMLoc- Streamlined Localization Using SCOUT® at Biopsy: An Analysis of Process Improvement, Cost Savings and Enhanced Patient Experience.
ClinicalTrials.gov ID: NCT04815291
Acronym / sponsor ID: SCOUT2021
Conditions: Breast Cancer
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision.
Enrolment: 93 participants (actual)
Lead sponsor: Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
Study start: 1 Apr 2022 (actual)
Primary completion: 15 Jan 2024 (actual)
Study completion: 15 Jan 2024 (actual)
First posted: 25 Mar 2021 (actual)
Results: Posted 21 May 2024

Clinical summary

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

This registry is intended to demonstrate the utility of SCOUT® in the Canadian public and US healthcare systems with fixed resources and a conservative approach to patient and clinician exposure to harm. The efficacy and safety of this system will be further assessed, as well as the acceptance of clinicians and patients.

Detailed description

This registry is intended to demonstrate the utility of SCOUT® in the Canadian public and US healthcare systems with fixed resources and a conservative approach to patient and clinician exposure to harm (i.e., radiation, COVID-19 exposure, patient emotional trauma). By assessing the utility of reflector insertion at the time of biopsy, this study will be able to measure the impact on patient visits to the breast center for invasive procedures between biopsy and surgery, and quantify this value to the public healthcare system. The efficacy and safety of this system will be further assessed, as well as the acceptance of clinicians and patients.

Study design

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

Arm	Type	Receives
Device	Experimental	Device: Receives SCOUT at biopsyReceives SCOUT at biopsy

Who may qualify

Ages: 18 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Woman >18 years and < 80 years of age;
Classified as Breast Imaging Reporting and Data System (BI-RADS) 4C or 5;
Lesion depth is < 6 cm from skin surface;
Non-palpable lesions;
Informed consent obtained.

Key exclusion criteria (3 listed)

Multicentric breast cancer;
Pregnant or lactating;
Known or suspected nickel-titanium allergy.

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
Receives SCOUT at biopsySCOUT Reflector	Device	Device

Primary outcome

Number of Participants Invasive Visits
Time frame: through study completion, an average of 6 months
Number of visits to the breast centre for an invasive procedure between biopsy and surgery

2 secondary outcomes

Number of Participants With Adverse Events
Time frame: through study completion; an average of 6 months
Performance
Time frame: through study completion; an average of 6 months

Results and safety

Results posted to the registry on 21 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Device	93	85

Primary outcome: Number of Participants Invasive Visits

Time frame: through study completion, an average of 6 months. Count of participants. Unit: Participants

Measure	Device n = 85
Value	5

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected through study completion; average of 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Device	0 of 93 (0%)	1 of 93 (1.1%)	0 of 93

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Breast Cancer

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Active, not recruitingPhase 1/2
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Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
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RecruitingPhase 3
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Active, not recruitingPhase 2
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Breast Cancer Stage IV

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.

C Desbiens, MD principal investigator

St. Sacrement

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

Questions about this trial

What is this clinical trial studying?

A study testing Receives SCOUT at biopsy in people with Breast Cancer, run by Merit Medical Systems, Inc. at 2 sites in Canada.

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 5 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: stopped early, as of the sponsor's last update on 21 May 2024. 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 Canada. 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 21 May 2024). 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 Invasive Visits (time frame: through study completion, an average of 6 months). 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 NCT04815291.

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 21 May 2024.