Magnetic Resonance Breast Tissue Characterisation to Improve Risk Stratification for Breast Cancer

NCT03684733 | Completed

• 1 other identifier: CCR 4173
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This is a combination retrospective/prospective observational study with two arms:

Conditions

BRCA1 Mutation; BRCA2 Mutation; Mammography; MRI

Keywords

Breast cancer; BRCA1/2 mutation carriers; Breast screening; Magnetic Resonance Imaging (MRI); X-ray mammography (XRM); Background Parenchymal Enhancement (BPE)

Outcome Measures

Primary Outcomes (4)

• Arm 1 (Cohort 1), Arm 2 (Cohorts 2 & 3) : breast density

  Breast density is measured in standard clinical sequences and in research sequences, expected to be the gold standard, as a %volume.

  After retrospective selection of subject groups (approximately 6 months).

• Arm 1 (Cohort 1), Arm 2 (Cohorts 2-3) : breast parenchyma enhancement (BPE)

  BPE is measured as a % of pre-contrast image intensity on dynamic contrast-enhanced examinations.

  After retrospective selection of subject groups (approximately 6 months).

• Arm 2 (Cohort 4): breast density

  Breast density is measured in standard clinical sequences and in research sequences, expected to be the gold standard, as a %volume.

  Six months after recruitment

• Arm 2 (Cohort 4): breast parenchyma enhancement (BPE)

  BPE is measured as a % of pre-contrast image intensity on dynamic contrast-enhanced examinations.

  Six months after recruitment

Study Arms (4)

Arm 1: Cohort 1 - Retrospective Analysis

Participants attending MRI \& XRM for a clinical indication with at least one normal breast

Diagnostic Test: MRI

Arm 2: Cohort 2 - Retrospective Analysis

BRCA1 or BRCA2 mutation carriers attending MRI \& XRM for breast screening: Genetic risk of breast cancer

Diagnostic Test: MRI

Arm 2: Cohort 3 - Retrospective Analysis

Participants attending MRI \& XRM for breast screening post mantle radiotherapy: Environmental risk of breast cancer

Diagnostic Test: MRI

Arm 2: Cohort 4 - Prospective

General population attending XRM for breast investigation: Population risk of breast cancer MRI

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

Clinical MRI breast screening examination

Arm 1: Cohort 1 - Retrospective Analysis; Arm 2: Cohort 2 - Retrospective Analysis; Arm 2: Cohort 3 - Retrospective Analysis; Arm 2: Cohort 4 - Prospective

Eligibility Criteria

• Age: 39 Years - 50 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Cohort 1: Retrospective breast MRI and XRM exam from participants with a clinical indication, reported as normal. Cohort 2: Retrospective breast MRI and XRM exams from genetically-proven BRCA1 or BRCA2 carriers; attendance at High Risk Breast Screening Service, RMH, and St George's Hospital (SGH). Cohort 3: Retrospective breast MRI and XRM exams from participants who received mantle radiotherapy at a young age and who subsequently attended the historic High Risk Breast Screening Service at RMH, or the High Risk Breast Screening Service at SGH. Cohort 4: Participants attending the RMH Rapid Diagnostic Assessment Centre for breast investigations who are found to have normal breast tissue on XRM will be prospectively invited for a breast MRI exam with administration of contrast agent.

You may qualify if:

• Cohort 1:
• Normal breast tissue in one or both breasts
• Aged \> 39.5 years
• ≤ 6 months between XRM and MRI examinations
• Cohort 2:
• Genetically proven BRCA1 or 2 mutation carrier
• Age 39.5 - 50.5 years
• ≤ 6 months between XRM and MRI examinations
• Cohort 3:
• Previous mantle radiotherapy
• Age 39.5 - 50.5 years
• ≤ 6 months between XRM and MRI examinations
• Cohort 4:
• Radiologically healthy breast tissue as assessed by XRM
• Age 39.5 - 50.5 years

You may not qualify if:

• Cohort 1:
• \- Treatment or medication between XRM and MRI examinations
• Cohort 2:
• Previous breast cancer diagnosis and/or treatment
• Treatment or medication between XRM and MRI examinations
• Cohort 3:
• Previous breast cancer diagnosis and/or treatment
• Treatment or medication between XRM and MRI examinations
• Cohort 4:
• Previous breast cancer diagnosis and/or treatment
• MRI incompatible implants
• Claustrophobia
• Inability to tolerate a 40 minute MRI breast examination
• Patients with renal failure or problems with IV access

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Steven Allen

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: September 26, 2018
• Study Start: March 13, 2017
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: March 13, 2020

Record last verified: 2020-03

Locations

GB (1)