CClinicalTrials.gg
Sign In
CompletedNCT00165412Updated May 2, 2019

Breast MRI Screening in Women Treated With Mediastinal Irradiation for Hodgkin's Disease

An observational study in Breast Cancer and Hodgkin's Disease, sponsored by Dana-Farber Cancer Institute. Completed at 3 sites in United States. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-05-02.

Sponsored by Dana-Farber Cancer Institute · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
148
Ages
20 Years and older
Sex
Female
01

Study 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 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.
02

Conditions studied

  • Breast Cancer
  • Hodgkin's Disease

Browse trials for

Keywords

  • Breast screening
  • Breast MRI
  • Mammogram
  • Mammography
03

In context

Hodgkin Disease

885 studies on the registry are indexed under Hodgkin Disease; 132 are open to participants now.

This study's enrollment of 148 is above the median of 130 across 119 observational studies indexed under Hodgkin Disease.

Browse Hodgkin Disease studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Survivors of Hodgkin's disease that have been previously received radiation therapy to the chest area

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
148 participants (actual)

Interventions

  • Procedurebreast MRI

    Repeated once a year for three years

  • ProcedureMammogram

    Repeated once a year for three years

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. To describe the MRI appearance and enhancing characteristics of breast cancer after Hodgkin's disease

    Time frame: 5 years

  2. to correlate the breast MRI findings and pathological findings

    Time frame: 5 years

  3. to determine the incidence of interval breast cancer in the screened population.

    Time frame: 5 years

07

Study locations

3 sites
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
  • Dana-Farber Cancer Center
    Boston, Massachusetts 02115, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00165412
Lead sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Beth Israel Deaconess Medical Center
Responsible party
Andrea K. Ng, MD (Radiation Oncologist, Dana-Farber Cancer Institute) — Principal investigator
First posted
Sep 14, 2005
Start date
Jul 2005
Primary completion
May 2010
Completion
May 2010
Last update
May 2, 2019

Study contacts

Andrea K. Ng, MD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hodgkin Disease→

Other studies from this sponsor

Dana-Farber Cancer Institute

Start the discussion