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

Breast Cancer Clinical Trial

Official title:

Breast MRI Screening in High-Risk Women After Mantle Radiation Therapy for Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00925405
• Other study ID #: 2009-0050
• Status: Terminated
• Phase: N/A
• First received: June 18, 2009
• Last updated: November 7, 2011
• Start date: June 2009
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• Breast MRI
Magnetic resonance imaging (MRI) scans of the breasts once per year
• Mammogram
Breast x-ray used to detect breast cancer and look for abnormalities in the breast.

Locations

Country	Name	City	State
United States	UT MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of breast cancer detected with addition of breast MRI		Once a year	No

External Links

•   UT MD Anderson Cancer Center website