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Breast Magnetic Resonance Imaging (MRI) Screening After Mantle Radiation Therapy

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ClinicalTrials.gov Identifier: NCT00925405
Recruitment Status : Terminated (Low accrual)
First Posted : June 22, 2009
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:

Objectives:

The objective of this single-arm, prospective study is to perform annual mammography and MRI breast cancer screening in women who underwent mantle-field irradiation between 1970-1995 at M. D. Anderson Cancer Center in order to compare the ability of MRI and standard mammography to identify breast cancer. In addition, we will determine whether the combination of breast MRI and mammography identifies smaller, earlier-stage tumors, which would lead to improved cure rates. We will also take the opportunity to determine the incidence and stage of breast cancer in this high-risk cohort.


Condition or disease Intervention/treatment
Breast Cancer Procedure: Breast MRI Procedure: Mammogram

Detailed Description:

Breast MRIs:

Breast MRIs have been reported to have higher sensitivity than mammograms for detecting early breast cancers, particularly in dense breasts where mammograms are not as effective. Although breast MRIs may add important information not provided by mammograms, the MRI must be used selectively. This is because the MRI is very sensitive and may show a false positive test (a test that shows cancer when there is none there).

Study Procedures:

If you are found to be eligible to take part in this study, the following procedures will be performed 1 time a year.

  • You will have a breast exam.
  • You will have a mammogram. A mammogram is a breast x-ray used to detect breast cancer and look for abnormalities in the breast.
  • You will have an MRI of your breasts. For the MRI, you will lay on your stomach while a large donut-shaped scanner takes images of your breasts.

If any abnormality is found, you will have routine follow-up procedures performed. Routine follow-up may include additional imaging scans or biopsies. These will follow the standard of care, and the information will be collected and stored in your medical record.

Length of Study:

You will be on study for 20 years, with annual check-ups with breast imaging studies at M. D. Anderson. You will be taken off study if there is a change in your health that will not allow a breast mammogram or MRI, such as becoming pregnant.

This is an investigational study.

Up to 223 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Design
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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Breast MRI Screening in High-Risk Women After Mantle Radiation Therapy for Lymphoma
Study Start Date : June 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Breast MRI Screening Procedure: Breast MRI
Magnetic resonance imaging (MRI) scans of the breasts once per year

Procedure: Mammogram
Breast x-ray used to detect breast cancer and look for abnormalities in the breast.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of breast cancer detected with addition of breast MRI [ Time Frame: Once a year ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women, breast cancer patients diagnosed with Hodgkin's lymphoma prior to 1995, who underwent mantle-field irradiation between 1970-1995 at M. D. Anderson Cancer Center.
Criteria

Inclusion Criteria:

  1. Female patients diagnosed with lymphoma prior to 1995
  2. The radiation therapy must have been delivered at M.D. Anderson from start to finish with complete records of dose received
  3. Patients must have received radiation therapy to the chest between the ages of 10 and 30

Exclusion Criteria:

  1. Patients with claustrophobia
  2. Obese patients (the equipment weight limit is 350 pounds and the maximum scanner bore diameter is 55 cm)
  3. Patients with myocardial infarction within 6 months of study entry
  4. Patients with unstable angina pectoris, uncontrolled congestive heart failure, or uncontrolled arrhythmias
  5. Patients with aneurysm clips, pacemakers, or other implanted devices that are not MRI compatible
  6. Pregnant patients
  7. Patients with compromised renal function, with a calculated glomerular filtration rate (cGFR) less than 60 ml/min/1.73m2.
  8. Patients who began their treatment outside of MD Anderson Cancer Center.
Contacts and Locations
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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): NCT00925405


Locations
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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Study Chair: Bouthaina Dabaja, MD UT MD Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00925405    
Other Study ID Numbers: 2009-0050
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011
Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Hodgkin's lymphoma
Mantle-field Irradiation
 Mammogram
Magnetic resonance imaging
MRI Breast Cancer Screening
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases