Screening MRI for Cancer Recurrence in Patients Treated With Breast Conserving Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Woo Kyung Moon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01257152
First received: December 8, 2010
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

A prospective, multicenter study:

  • Primary objective: to assess the diagnostic yield of screening MRI compared to physical examination, mammography or ultrasonography in the detection of recurrence in patients treated with breast conserving therapy
  • Secondary objective: to describe the size, type, grade, and nodal status of cancers seen only on MRI and to estimate the rate of benign biopsies and short interval follow-up induced only by MRI in this population.

Condition
Breast Neoplasms
Neoplasm Recurrence, Local

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Screening MRI for Cancer Recurrence in Patients Treated With Breast Conserving Therapy

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Diagnostic yield of screening breast MRI [ Time Frame: Three years after the first screening MRI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensitivity, specificity, negative predictive value, and positive predictive value of screening mammography, ultrasonography, and MRI [ Time Frame: Three years after the first screening examinations ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Complications of the MRI contrast agents [ Time Frame: Three years after the first screening MRI ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 750
Study Start Date: December 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Detailed Description:
  • Patients treated with breast conserving therapy will be followed for recurrence in the ipsilateral or contralateral breast by physical examination every six month and imaging studies performed annually.
  • The imaging including mammography, physician-performed bilateral whole breast ultrasonography and a dynamic breast MRI with gadolinium-containing contrast medium will be performed according to a standard protocol. Interpretation will be conducted independently and classified according to the Breast Imaging Reporting and Data System (BI-RADS) by experienced radiologists.
  • Definitive information about the presence of malignancy will be obtained by biopsy directed by the imaging method best depicting the lesion with 14-g or 11-g needle devices or needle localized excision. The absence of breast cancer was determined by means of biopsy, the absence of positive findings on repeat imaging and clinical examination, or both at follow-up.
  • After three rounds of annual screening, the diagnostic yield of screening MRI compared to physical examination, mammography or ultrasonography will be assessed.
  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Breast cancer patients undergoing conservation surgery and radiation therapy

Criteria

Inclusion Criteria:

  • Women ≥ 20 years in age;
  • Women who underwent breast-conserving surgery for invasive breast cancer, whose final margins were negative and who finished radiation therapy at least 6 months prior to this study;
  • No history of breast biopsy of the breast within 6 months prior to this study;
  • Signed study-specific informed consent prior to registration;
  • Has not had contralateral mastectomy;
  • No known metastatic disease;
  • Not pregnant or lactating;
  • No present signs or symptoms of breast cancer [no palpable mass(es), bloody or spontaneous clear nipple discharge, axillary mass, or abnormal skin changes in the breast(s) or nipple(s)].
  • No contraindications to MRI examination.
  • No prior MRI, US or mammography within the 6 months prior to the study.

Exclusion Criteria:

  • Had a screening contrast-enhanced breast MRI within the past 24 months or diagnostic contrast-enhanced MRI on any study breasts within the past 12 months;
  • Had breast surgery and/or a core biopsy on the study breast(s) performed within the prior 6 months on the study
  • Currently receiving chemotherapy [with exception to participant with personal history of cancer, and on chemoprevention with Tamoxifen, Evista (Raloxifene), Arimidex (Anastrozole), Aromasin (Exemestane) or other aromatase inhibitor];
  • Participant with severely impaired renal function with estimated glomerular filtration rate (GFR) < 30 mL/min/1.73m2 and/or on dialysis.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257152

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Woo Kyung Moon, M.D., Ph.D. Department of Radiology, Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Woo Kyung Moon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01257152     History of Changes
Other Study ID Numbers: Screening MR for Recurred BrCa
Study First Received: December 8, 2010
Last Updated: March 11, 2013
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasm Recurrence, Local
Recurrence
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on August 28, 2014