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

NCT01257152 | Completed

• 1 other identifier: Screening MR for Recurred BrCa
• Study Type: observational
• Target: 754
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Neoplasm Recurrence, Local

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield of screening breast MRI

  Three years after the first screening MRI

Secondary Outcomes (1)

• Sensitivity, specificity, negative predictive value, and positive predictive value of screening mammography, ultrasonography, and MRI

  Three years after the first screening examinations

Other Outcomes (1)

• Complications of the MRI contrast agents

  Three years after the first screening MRI

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients undergoing conservation surgery and radiation therapy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Recurrence, Local

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Woo Kyung Moon, M.D., Ph.D.

  Department of Radiology, Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 9, 2010
• Study Start: December 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

KR (1)