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FAST MRI Study in Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT02244593
Recruitment Status : Recruiting
First Posted : September 19, 2014
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Jean Seely, Ottawa Hospital Research Institute

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Other: FAST MRI and mammography screening Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: FAST MRI Study in Breast Cancer Survivors
Study Start Date : October 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Mammography screening only

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.

Experimental: FAST MRI and mammogram screening
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
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.
Other Name: FAST MRI




Primary Outcome Measures :
  1. The percentage of patients with reduced anxiety as a result of having a FAST MRI [ Time Frame: up to 12 months ]

Secondary Outcome Measures :
  1. Numbers of recurrent tumors in each arm [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Number of tumors missed by mammography [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02244593


Contacts
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Contact: Jean Seely, MD FRCPC 613-737-8899 ext 73665 jeseely@toh.on.ca
Contact: Betty Anne Schwarz, RN BA MSc 613-798-5555 ext 17522 baschwarz@toh.on.ca

Locations
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Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 9L6
Principal Investigator: Jean Seely, MD FRCPC         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Jean Seely, MD FRCPC Ottawa Hospital Research Institute

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Responsible Party: Jean Seely, Dr. Jean Seely, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02244593    
Other Study ID Numbers: OHSN-REB 20140103-01H
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Planning on submitting preliminary results to RSNA 2017 and full publication by Oct 2018.
Keywords provided by Jean Seely, Ottawa Hospital Research Institute:
breast cancer survivors
FAST MRI
mammography screening
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases