FAST MRI Study in Breast Cancer Survivors

NCT02244593 | Completed

• 1 other identifier: OHSN-REB 20140103-01H
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

Breast Magnetic Resonance Imaging (MRI) has been shown to be the most accurate test for detecting breast cancer however, MRI is not always reliable because it can indicate the presence of cancer when in reality, there is none; this is called a 'false positive' result. A history of breast carcinoma alone does not qualify a patient for ongoing monitoring with breast MRI. This study is being done to assess a new technique called FAST breast MRI. A FAST breast MRI is different than a traditional breast MRI because it has much fewer sequences and takes approximately 3 minutes for the scan. MRI sequences are combinations of magnetic pulses that collect information about the tissues. There is no radiation associated with an MRI. The purpose of this study is to determine the impact on patient health when a FAST breast MRI is used as a screening technique in women with a personal history of cancer. It has been shown that FAST breast MRI is similar to routine breast MRI in the detection of breast cancer, but it has not been proven that FAST breast MRI will help women who have a personal history for breast cancer. Currently, routine breast MRI is not part of the standard of care in screening for breast cancer in women who have a prior personal history of breast cancer. By evaluating FAST MRI the investigators are able to study the effects of this short MRI on cancer detection in women with a personal history of breast cancer, and on the impact on overall health. The investigators estimate that 300 participants will be enrolled in the study from The Ottawa Hospital Cancer Centre at The Ottawa Hospital, General Campus and the Women's Breast Health Centre at The Ottawa Hospital, Civic Campus. All of the participants have had a history of breast carcinoma.

Conditions

Breast Cancer

Keywords

breast cancer survivors; FAST MRI; mammography screening

Outcome Measures

Primary Outcomes (1)

• The percentage of patients with reduced anxiety as a result of having a FAST MRI

  up to 12 months

Secondary Outcomes (1)

• Numbers of recurrent tumors in each arm

  12 months

Other Outcomes (1)

• Number of tumors missed by mammography

  12 months

Study Arms (2)

Mammography screening only

NO INTERVENTION

This group will receive their standard of care mammogram only. Participants in this arm will not receive the FAST MRI. Participants will complete 4 questionnaires at 3 time points: enrollment; 2 weeks after they receive their mammogram; 6 months after their mammogram.

FAST MRI and mammogram screening

EXPERIMENTAL

Patients in this group will receive Breast MRI and annual mammography. Participants will complete 4 questionnaires at 3 time points: enrollment; 2 weeks after they receive their mammogram; 6 months after their mammogram. The intervention is the addition of the FAST Breast MRI.

Other: FAST MRI and mammography screening

Interventions

FAST MRI and mammography screening OTHER

Patients in this group will receive Breast MRI and annual mammography. Participants will complete 4 questionnaires at 3 time points: enrollment; 2 weeks after they receive their mammogram; 6 months after their mammogram.

Also known as: FAST MRI

FAST MRI and mammogram screening

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English or French speaking female patients over the age of 18 years, with a personal history of a diagnosis of breast carcinoma (including ductal carcinoma in situ (DCIS) and invasive ductal or lobular carcinoma) within the past 10 years.
• Patients must have completed treatment for their breast cancer.
• Moderate risk for recurrence of breast cancer, defined as lifetime risk of breast cancer greater than 12% (average risk) and less than 25% (high risk) as defined using the Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm (BOADICEA) model (see Appendix A)
• Patients who have undergone unilateral mastectomy or breast conservation surgery.
• Normal renal function: estimated glomerular filtration rate (eGFR) \> 30 ml/min/m2

You may not qualify if:

• Patients unable to undergo an MRI, due to either physical or mental issues (i.e.: anxiety or severe claustrophobia). Also, patient with a known allergy to gadolinium, or severe renal failure will be excluded.
• Pregnant or breastfeeding patients.
• Patients who have had a breast MRI within the last 6 months.
• Patients already receiving high-risk breast MRI screening, such as the Ontario Breast Screening Program (OBSP) high-risk program and the Women's Breast Health Center (WBHC) high-risk program.
• Patients who have undergone bilateral mastectomies.
• Poor renal function: estimated glomerular filtration rate (eGFR) \< 30 ml/min/m2

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 9L6, Canada

Location

Related Publications (1)

• Fonseca MM, Alhassan T, Nisha Y, Koszycki D, Schwarz BA, Segal R, Arnaout A, Ramsay T, Lau J, Seely JM. Randomized trial of surveillance with abbreviated MRI in women with a personal history of breast cancer- impact on patient anxiety and cancer detection. BMC Cancer. 2022 Jul 15;22(1):774. doi: 10.1186/s12885-022-09792-x.

  PMID: 35840916 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jean Seely, MD FRCPC

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Jean Seely

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: September 19, 2014
• Study Start: October 1, 2014
• Primary Completion: September 25, 2020
• Study Completion: September 25, 2020
• Last Updated: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)