Breast CancerNCT00925405
Breast Magnetic Resonance Imaging (MRI) Screening After Mantle Radiation Therapy
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast MRI and Mammogram
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Female patients diagnosed with lymphoma prior to 1995
- The radiation therapy must have been delivered at M.D. Anderson from start to finish with complete records of dose received
- Patients must have received radiation therapy to the chest between the ages of 10 and 30
Who cannot join
- Patients with claustrophobia
- Obese patients (the equipment weight limit is 350 pounds and the maximum scanner bore diameter is 55 cm)
- Patients with myocardial infarction within 6 months of study entry
- Patients with unstable angina pectoris, uncontrolled congestive heart failure, or uncontrolled arrhythmias
- Patients with aneurysm clips, pacemakers, or other implanted devices that are not MRI compatible
- Pregnant patients
- Patients with compromised renal function, with a calculated glomerular filtration rate (cGFR) less than 60 ml/min/1.73m2.
- Patients who began their treatment outside of MD Anderson Cancer Center.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breast MRI Screening in High-Risk Women After Mantle Radiation Therapy for Lymphoma
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Breast MRI, Mammogram
- Keywords
- Breast Cancer, Hodgkin's lymphoma, Mantle-field Irradiation, Mammogram, Magnetic resonance imaging, MRI Breast Cancer Screening
- Medical subject headings
- Breast Neoplasms, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast MRIProcedure or surgery
Magnetic resonance imaging (MRI) scans of the breasts once per year
MammogramProcedure or surgery
Breast x-ray used to detect breast cancer and look for abnormalities in the breast.
| Study group | Role | What they receive |
|---|---|---|
| Breast MRI Screening | Not described Receives: Procedure: Breast MRI; Procedure: Mammogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of breast cancer detected with addition of breast MRI
Measured: Once a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bouthaina Dabaja, MD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925405
- Sponsor's protocol ID
- 2009-0050
- Status last verified
- Nov 2011
- First submitted
- 18 Jun 2009
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast MRI Screening in High-Risk Women After Mantle Radiation Therapy for Lymphoma
- ClinicalTrials.gov ID
- NCT00925405
- Acronym / sponsor ID
- 2009-0050
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Hodgkin's lymphoma, Mantle-field Irradiation, Mammogram, Magnetic resonance imaging, MRI Breast Cancer Screening
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 10 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 22 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast MRI Screening | – | Procedure: Breast MRI, Procedure: Mammogram |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Female patients diagnosed with lymphoma prior to 1995
- The radiation therapy must have been delivered at M.D. Anderson from start to finish with complete records of dose received
- Patients must have received radiation therapy to the chest between the ages of 10 and 30
Key exclusion criteria (8 listed)
- Patients with claustrophobia
- Obese patients (the equipment weight limit is 350 pounds and the maximum scanner bore diameter is 55 cm)
- Patients with myocardial infarction within 6 months of study entry
- Patients with unstable angina pectoris, uncontrolled congestive heart failure, or uncontrolled arrhythmias
- Patients with aneurysm clips, pacemakers, or other implanted devices that are not MRI compatible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast MRIMagnetic resonance imaging (MRI) scans of the breasts once per year | Procedure or surgery | Breast MRI Screening |
| MammogramBreast x-ray used to detect breast cancer and look for abnormalities in the breast. | Procedure or surgery | Breast MRI Screening |
Primary outcome
Incidence of breast cancer detected with addition of breast MRI
Time frame: Once a year
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bouthaina Dabaja, MD study chair
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of breast cancer detected with addition of breast MRI (time frame: Once a year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2011.