Clinical trial NCT01257152: Screening MRI for Cancer Recurrence in Patients Treated With Breast Conserving Therapy
Official title: Screening MRI for Cancer Recurrence in Patients Treated With Breast Conserving Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Neoplasm Recurrence, Local
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-12-09
Enrollment: 754
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients undergoing conservation surgery and radiation therapy

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.

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 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.

Primary outcomes:
measure: Diagnostic yield of screening breast MRI
timeFrame: Three years after the first screening MRI
Secondary outcomes:
measure: Sensitivity, specificity, negative predictive value, and positive predictive value of screening mammography, ultrasonography, and MRI
timeFrame: Three years after the first screening examinations
Other outcomes:
measure: Complications of the MRI contrast agents
timeFrame: Three years after the first screening MRI
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Department of Radiology, Seoul National University Hospital
name: Woo Kyung Moon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: