Abbreviated Breast MRI for Second Breast Cancer Detection... | NCT03475979

Studies
Abbreviated Breast MRI for Second Breast Cancer Detection in Women With BRCA Mutation Testing

NCT03475979

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Nov 30, 2020Actual

Enrollment

1,564Estimated

Phase

Not provided

Conditions

Breast Cancer
BRCA1 Mutation
BRCA2 Mutation
Recurrent Breast Cancer
Metachronous Neoplasm

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2018Actual

Primary Completion Date

Jun 2022Estimated

Completion Date

Jun 2022Estimated

First Submitted Date

Mar 13, 2018

First Submission Date that Met QC Criteria

Mar 18, 2018

First Posted Date

Mar 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2020

Last Update Posted Date

Nov 30, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Woo Kyung Moon, Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Name	Class
Korean Society of Breast Imaging & Korean Society For Breast Screening	UNKNOWN
Bayer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Study Purpose:

A multicenter prospective study to evaluate the outcome of second breast cancer surveillance with abbreviated breast MR (AB-MR) or ultrasound (US) in addition to annual mammography in women with BRCA1/2 mutation testing

Study Scheme:

AB-MR, US, and digital mammography will be performed on the same day and interpreted independently at baseline and then after 1 year.
After completion of study, patients are followed-up for at least 1 year.

Detailed Description

For women with a BRCA1/2 mutation who are treated for breast cancer, screening of remaining breast tissue with annual mammography and breast MRI is recommended. For women who met BRCA testing criteria but show an uninformative negative result or a variant of unknown significance (VUS) result, there is no established recommendation for second breast cancer surveillance.

Abbreviated breast MRI (AB-MR) is a fast and low-cost examination that show equivalent diagnostic accuracy to that of the standardized dynamic protocol breast MRI. Breast ultrasound (US) can detect additional cancers that are occult on mammography and is indicated in high-risk patients who cannot tolerate MRI.

The purpose of this multicenter prospective study is to evaluate the outcome of second breast cancer surveillance with AB-MR or US in addition to annual mammography in women with BRCA1/2 mutation testing.

AB-MR, US, and digital mammography will be performed on the same day at baseline and then after 1 year and images will be interpreted independently according to the Breast Imaging Reporting and Data System (BI-RADS) by experienced radiologists. The BI-RADS category 3 or higher is defined as test-positive. The reference standard will be a biopsy or at least 1 year of follow-up.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,564Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity and Specificity (co-primary)	To compare the sensitivity and specificity of AB-MR, US, and mammography for the detection of secondary breast cancer	1 year

Secondary Outcomes

Measure	Description	Time Frame
Cancer detection rate (CDR)	To compare the CDR (no. of detected cancers/1,000 examinations) of AB-MR, US, and mammography	1 year
Positive predictive value (PPV)	To compare the PPV (no. of detected cancers / no. of positive examinations) of AB-MR, US, and mammography

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women aged between 25 years and 75 years with a personal history of breast cancer
BRCA mutation test done (meeting any of the following criteria): 1) early-age-onset breast cancer (40 years or younger), 2) bilateral breast cancers (synchronous) 3) personal history of ovarian cancer and/or other multiple primary cancers 4) family history of breast and/or ovarian cancer in first- or second-degree relatives
No symptom or sign of secondary breast cancer (no palpable mass, bloody nipple discharge, abnormal skin change, nipple retraction)
Written informed consent is given

Exclusion criteria:

Initial breast cancer stage IV
Bilateral mastectomy done
Diagnosis of second breast cancer or regional/distant metastasis
Systemic chemotherapy for any cancer
Pregnant or lactating
Contraindication to breast MRI with contrast enhancement

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Breast cancer patients who met BRCA testing criteria and undergo post-operative surveillance for secondary breast cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Woo Kyung Moon, MD, PhD	Contact	82-2-2072-2584		moonwk@snu.ac.kr

Overall Officials

Name	Affiliation	Role
Woo Kyung Moon, MD, PhD	Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D016609	Neoplasms, Second Primary

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided