Breast CancerNCT00165412
Breast MRI Screening in Women Treated With Mediastinal Irradiation for Hodgkin's Disease
An observational study of Breast Cancer and Hodgkin's Disease, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
The purpose of this study is to determine if the use of breast MRI in detecting breast malignancies in survivors of Hodgkin's disease is more successful than the traditional mammogram. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer, Hodgkin's Disease
- What is being tested?
- breast MRI and Mammogram
- Type of treatment
- Surgery or procedure
- How many people
- 148 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2005to May 2010
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Survivors of Hodgkin's disease that have been previously received radiation therapy to the chest area
Who may be able to join
- Female patients treated with radiation therapy to the chest area for Hodgkin's disease
- Age between 12 and 35 at initial treatment
- Eight years or longer after initial treatment
- Pre-approval from the participant's insurance company for the breast imaging studies
Who cannot join
- Pregnant or lactating women
- Post Bilateral mastectomy
- Currently undergoing breast cancer therapy
- Known metastatic cancer
- Patients with contraindications for undergoing an MRI: cardiac pacemaker, known metallic objects in body e.g. metallic clips, bullets, shrapnel or buckshots.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Center
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The purpose of this study is to determine if the use of breast MRI in detecting breast malignancies in survivors of Hodgkin's disease is more successful than the traditional mammogram.
Read the detailed description
- The screening breast MRI and mammography will be performed 6 months or longer after the last mammogram. For pre-menopausal women, the screening will be performed during the second week of the menstrual cycle to reduce cycle-related breast changes. As much as possible, the breast MRI and mammogram are to be performed on the same day.
- On the day of the breast imaging studies, the patient will also be asked to fill out a baseline breast health questionnaire, which includes questions on time since radiation therapy, prior screening history, history of prior benign breast biopsies, menopausal status, prior hormonal therapy use, etc.
- In patients with suspicious findings or findings highly suggestive of malignancy, the abnormal findings will be reviewed with the patient and recommendations will be made for a biopsy.
- Conditions
- Breast Cancer, Hodgkin's Disease
- Being tested
- breast MRI, Mammogram
- Keywords
- Breast screening, Breast MRI, Mammogram, Mammography
- 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
Repeated once a year for three years
MammogramProcedure or surgery
Repeated once a year for three years
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the sensitivity, specificity, positive and negative predictive value of mammography and breast MRI for breast cancer detection in women treated for Hodgkin's disease.
Measured: 5 years
Secondary outcomes (3)
To describe the MRI appearance and enhancing characteristics of breast cancer after Hodgkin's disease
Measured: 5 years
to correlate the breast MRI findings and pathological findings
Measured: 5 years
to determine the incidence of interval breast cancer in the screened population.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea K. Ng, MD, Dana-Farber Cancer Institute
- Investigators
- Andrea K. Ng, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165412
- Sponsor's protocol ID
- 05-241
- Status last verified
- Apr 2019
- First submitted
- 9 Sep 2005
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ng AK, Garber JE, Diller LR, Birdwell RL, Feng Y, Neuberg DS, Silver B, Fisher DC, Marcus KJ, Mauch PM. Prospective study of the efficacy of breast magnetic resonance imaging and mammographic screening in survivors of Hodgkin lymphoma. J Clin Oncol. 2013 Jun 20;31(18):2282-8. doi: 10.1200/JCO.2012.46.5732. Epub 2013 Apr 22.
PubMed 23610104
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast MRI Screening in Women Treated With Mediastinal Irradiation for Hodgkin's Disease
- ClinicalTrials.gov ID
- NCT00165412
- Acronym / sponsor ID
- 05-241
- Conditions
- Breast Cancer, Hodgkin's Disease
- Keywords
- Breast screening, Breast MRI, Mammogram, Mammography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Beth Israel Deaconess Medical Center
- Study start
- Jul 2005
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 14 Sep 2005 (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.
The purpose of this study is to determine if the use of breast MRI in detecting breast malignancies in survivors of Hodgkin's disease is more successful than the traditional mammogram.
Detailed description
- The screening breast MRI and mammography will be performed 6 months or longer after the last mammogram. For pre-menopausal women, the screening will be performed during the second week of the menstrual cycle to reduce cycle-related breast changes. As much as possible, the breast MRI and mammogram are to be performed on the same day.
- On the day of the breast imaging studies, the patient will also be asked to fill out a baseline breast health questionnaire, which includes questions on time since radiation therapy, prior screening history, history of prior benign breast biopsies, menopausal status, prior hormonal therapy use, etc.
- In patients with suspicious findings or findings highly suggestive of malignancy, the abnormal findings will be reviewed with the patient and recommendations will be made for a biopsy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Survivors of Hodgkin's disease that have been previously received radiation therapy to the chest area
Key inclusion criteria (4 listed)
- Female patients treated with radiation therapy to the chest area for Hodgkin's disease
- Age between 12 and 35 at initial treatment
- Eight years or longer after initial treatment
- Pre-approval from the participant's insurance company for the breast imaging studies
Key exclusion criteria (5 listed)
- Pregnant or lactating women
- Post Bilateral mastectomy
- Currently undergoing breast cancer therapy
- Known metastatic cancer
- Patients with contraindications for undergoing an MRI: cardiac pacemaker, known metallic objects in body e.g. metallic clips, bullets, shrapnel or buckshots.
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 MRIRepeated once a year for three years | Procedure or surgery | – |
| MammogramRepeated once a year for three years | Procedure or surgery | – |
Primary outcome
To compare the sensitivity, specificity, positive and negative predictive value of mammography and breast MRI for breast cancer detection in women treated for Hodgkin's disease.
Time frame: 5 years
3 secondary outcomes
To describe the MRI appearance and enhancing characteristics of breast cancer after Hodgkin's disease
Time frame: 5 years
to correlate the breast MRI findings and pathological findings
Time frame: 5 years
to determine the incidence of interval breast cancer in the screened population.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Derived from this study: PubMed 23610104Ng AK, Garber JE, Diller LR, Birdwell RL, Feng Y, Neuberg DS, Silver B, Fisher DC, Marcus KJ, Mauch PM. Prospective study of the efficacy of breast magnetic resonance imaging and mammographic screening in survivors of Hodgkin lymphoma. J Clin Oncol. 2013 Jun 20;31(18):2282-8. doi: 10.1200/JCO.2012.46.5732. Epub 2013 Apr 22.
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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.
Andrea K. Ng, MD principal investigator
Dana-Farber Cancer Institute
3 sites 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 and Hodgkin's Disease, run by Dana-Farber Cancer Institute at 3 sites 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare the sensitivity, specificity, positive and negative predictive value of mammography and breast MRI for breast cancer detection in women treated for Hodgkin's disease. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00165412, which also lists 1 linked publication.
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 2 May 2019.