Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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.

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.

FAST MRI and mammography screening

Jean Seely, MD FRCPC

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.

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.

FAST MRI Study in Breast Cancer Survivors

Planning on submitting preliminary results to RSNA 2017 and full publication by Oct 2018.

Ottawa Hospital Research Institute

Dr. Jean Seely

All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.

The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.

Fast MRI

Gregory Hundley, MD

The overall of this proposal is to test in community hospitals the utility of a 10-min magnetic resonance imaging (MRI) scan protocol combined with proprietary image analysis algorithms for detecting early cardiovascular (CV) injury during receipt of chemotherapy for breast cancer (BrC) and lymphoma. This technology provides health-care delivery systems with a time-efficient method to identify those at risk of a future CV event so that prevention can be implemented to prolong survival and reduce morbidity in cancer survivors.

While recent research indicates that conventional MRI, advanced echocardiography (global longitudinal strain and 3D) and serum biomarkers can detect CV injury early after receipt of Chemotherapy, these methods require lengthy and difficult examinations that are not routinely executed in community hospitals where the majority of patients with BrC \& lymphoma are treated. Yet, 1-month deteriorations in traditional 45-min MRI measures are known to forecast 6-month subclinical deteriorations in left ventricular ejection fraction (LVEF) that are associated with CV events. At the same time, new observational data indicate therapy with HMG-CoA reductase inhibitors/statins administered early during receipt of Chemotherapy may prevent subsequent cardiac dysfunction and CV events. Our MRI fast scanning techniques remedy these community hospital implementation obstacles.

In this proposal, the investigators propose to test the utility of these fast scans within an existing funded randomized clinical trial R01HL118740 of generic atorvastatin that is researching methods to prevent cardiotoxicity in patients treated with Chemotherapy for BrC and lymphoma (taking advantage of significant existing clinical trial resources). This study allows us to address our over-arching goal: to determine the optimal implementation (alone or in combination with other tests) of our proprietary MRI processes for forecasting CV injury in patients treated with Chemotherapy in community hospitals through performance of a Phase II comparative effectiveness study within an ongoing clinical trial.

Community Hospital Identification of High CV Risk Patients During Cancer Treatment

Community Hospital Identification of High CV Risk Patients During Cancer Treatment (CHI)

To use exploratory algorithmic modeling to obtain optimal strategies for determining the combination of metrics (10-min MR, ECHO, serum biomarkers) at 2-months that predict the 6-month post Chemotherapy deteriorations in cardiovascular function.

To compare baseline, 2-month (using Fast MRI), and 6 month measures in left ventricular (LV) ejection fraction

To compare baseline, 2-month (using Fast MRI), and 6 month measures in end Diastolic Volume (EDV)

To compare baseline, 2-month (using Fast MRI), and 6 month measures in end Systolic Volume (ESV)

To compare baseline and 6 month measures in pulse wave velocity (PWV)

To compare Magnetic Resonance Imaging (MRI) metric of Left Ventricular Ejection Fraction (LVEF) with Echocardiogram (ECHO) at baseline

To compare magnetic resonance imaging (MRI) metric of End Diastolic Volume (EDV) with echocardiogram (ECHO) at baseline

To compare magnetic resonance imaging (MRI) metric of End Systolic Volume (ESV) with echocardiogram (ECHO) at baseline

Wake Forest University Health Sciences

Grades 1, 2, and 3 expected (solicited) and unexpected (unsolicited) adverse events (AE)s that meet the above definition for an AE and are only definitely related, possibly related or probably related to this study intervention should be reported using the Toxicity Assessment Sheet. Hospitalizations that are scheduled for routine treatments and procedures unrelated to study intervention do not need to be reported. All toxicities are graded using CTCAE v4.03.

All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.

Fast MRI: The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Left Ventricular Ejection Fraction (LVEF)

End Diastolic Volume (EDV) - Magnetic Resonance Imaging (MRI)

End Systolic Volume (ESV) - Magnetic Resonance Imaging (MRI)

Pulse Wave Velocity (PWV) - Magnetic Resonance Imaging (MRI)

Left Ventricular Ejection Fraction (LVEF) - Echocardiogram (ECHO)

End Diastolic Volume (EDV) - Echocardiogram (ECHO)

End Systolic Volume (ESV) - Echocardiogram (ECHO)

Early termination leading to small number of subject analyzed.

Correlation between baseline and 2 months.

Correlation between baseline and 6 months.

2 months FAST MRI

6 months

Only 5 received MRI at baseline, 4 at 2 months using Fast MRI, and 3 at 6 months.

Left Ventricular Ejection Fraction (LVEF) at Baseline, 2 Month Using Fast MRI, and 6 Months

End Diastolic Volume (EDV) at Baseline, 2 Month, and 6 Months

End Systolic Volume (ESV) at Baseline, 2 Month, and 6 Months

Baseline

Only 5 received MRI at baseline and 3 at 6 months.

Pulse Wave Velocity (PWV) at Baseline and 6 Months

LVEF Echo

LVEF MRI

All 6 participants that received both an ECHO. Only 5 had an MRI at baseline

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
FAST MRI Study in Breast Cancer Survivors	NCT02244593	Breast Cancer	FAST MRI and ma...	18 Years -	Ottawa Hospital Research Institute
Community Hospital Identification of High CV Risk Patients During Cancer Treatment	NCT02566109	Breast Cancer	Fast MRI	21 Years -	Wake Forest University Health Sciences

Spots Global Cancer Trial Database for fast mri

Every month we try and update this database with for fast mri cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fast mri

Every month we try and update this database with for fast mri cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fast mri cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.