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

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ClinicalTrials.gov Identifier: NCT01257152
Recruitment Status : Completed
First Posted : December 9, 2010
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Woo Kyung Moon, Seoul National University Hospital

Brief Summary:

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 or disease
Breast Neoplasms Neoplasm Recurrence, Local

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.

Study Type : Observational
Actual Enrollment : 754 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Screening MRI for Cancer Recurrence in Patients Treated With Breast Conserving Therapy
Study Start Date : December 2010
Primary Completion Date : January 2016
Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Diagnostic yield of screening breast MRI [ Time Frame: Three years after the first screening MRI ]

Secondary Outcome Measures :
  1. Sensitivity, specificity, negative predictive value, and positive predictive value of screening mammography, ultrasonography, and MRI [ Time Frame: Three years after the first screening examinations ]

Other Outcome Measures:
  1. Complications of the MRI contrast agents [ Time Frame: Three years after the first screening MRI ]


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016

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