search
Back to results

FAST MRI Study in Breast Cancer Survivors

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
FAST MRI and mammography screening
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring breast cancer survivors, FAST MRI, mammography screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • The Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Mammography screening only

FAST MRI and mammogram screening

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Numbers of recurrent tumors in each arm

Full Information

First Posted
June 6, 2014
Last Updated
September 24, 2020
Sponsor
Ottawa Hospital Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT02244593
Brief Title
FAST MRI Study in Breast Cancer Survivors
Official Title
FAST MRI Study in Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
September 25, 2020 (Actual)
Study Completion Date
September 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Given the demand for breast MRI screening by breast cancer survivors and oncologists, we plan to perform a randomized controlled trial in a select patient population of breast cancer survivors who would not normally be eligible for breast MRI screening. This study will determine whether using FAST MRI in addition to mammography will reduce anxiety in patients compared to the current standard of care: mammography alone. If it turns out to reduce anxiety, the next step would be to conduct a large-scale multi-centre randomized control trial (RCT) to evaluate whether FAST MRI is more sensitive and whether the increased sensitivity leads to improved clinical outcomes. The purpose of our study is to determine the impact on patient anxiety of FAST Breast MRI as a surveillance technique in women with a personal history of breast cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer survivors, FAST MRI, mammography screening

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mammography screening only
Arm Type
No Intervention
Arm Description
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.
Arm Title
FAST MRI and mammogram screening
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
FAST MRI and mammography screening
Other Intervention Name(s)
FAST MRI
Intervention Description
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.
Primary Outcome Measure Information:
Title
The percentage of patients with reduced anxiety as a result of having a FAST MRI
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Numbers of recurrent tumors in each arm
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Number of tumors missed by mammography
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Seely, MD FRCPC
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 9L6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Planning on submitting preliminary results to RSNA 2017 and full publication by Oct 2018.
Citations:
PubMed Identifier
35840916
Citation
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. Erratum In: BMC Cancer. 2022 Sep 23;22(1):1009.
Results Reference
derived

Learn more about this trial

FAST MRI Study in Breast Cancer Survivors

We'll reach out to this number within 24 hrs