Study Stopped
No patient accrual
MRI in Predicting Tumor Reponse After Radiofrequency Ablation in Women With Invasive Breast Cancer
Breast MRI Assessment of Tumor Viability After Radiofrequency Ablation (RFA)
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Diagnostic procedures, such as magnetic resonance imaging (MRI), may help in learning how well radiofrequency ablation works to kill breast cancer cells and help doctors predict whether breast cancer cells remain after treatment. PURPOSE: This phase II trial is studying how well MRI works in predicting tumor response after radiofrequency ablation in women with invasive breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2005
Typical duration for phase_2 breast-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 6, 2006
CompletedFirst Posted
Study publicly available on registry
September 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedDecember 5, 2017
December 1, 2017
5.3 years
September 6, 2006
December 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Tumor Necrosis
Efficacy of radiofrequency ablation (RFA) in inducing complete tumor necrosis as measured by immunohistochemical and biomarker studies.
Secondary Outcomes (3)
Sensitivity and specificity of delayed dynamic contrast-enhanced MRI (DCE-MRI) in detecting residual cancer after RFA as measured by the Hylton method
Cosmetic Outcome
after RFA but before definitive surgery
Toxicity or complications of RFA
before definitive surgery
Study Arms (1)
RadioFrequency Ablation for Breast Cancer
EXPERIMENTALInterventions
Standard lumpectomy or mastectomy will be performed 1 to 21 days after the post-RFA MRI.
Dynamic-contrast enhanced breast images will be visualized with parametric image maps to assist in identifying regions with residual cancer.
RFA is accomplished by placing a multi-array needle within a tumor. The tines of the needle are advanced and opened like an inverted umbrella. High frequency, alternating current moves from the tip of an electrode into the surrounding tissue. Oscillating ions generate frictional heat within the tumor. Cell death occurs at sustained temperatures above 45-50 degrees C. The multi-array configuration creates an egg-shaped ablation zone up to 5 cm in diameter.
Injected at baseline MRI and post radiofrequency ablation MRI.
Eligibility Criteria
You may qualify if:
- Diagnosis of invasive breast cancer - the following information must be known based on the needle core biopsy: tumor grade, hormone receptor status, and HER2/neu status. Patients with a previous history of either ipsilateral or contralateral excisional biopsy are not excluded. However, patients are excluded if an excisional biopsy was used to diagnose the current breast cancer.
- Note: Subjects undergoing sentinel lymph node (SLN) biopsy will not be excluded from this research study. It is not expected that radiofrequency ablation (RFA) will interfere with the SLN procedure because other studies have demonstrated the accuracy of sentinel node staging after excisional biopsy. The axillary staging in these subjects will be noted.
- Tumor size \< 2 centimeters by mammogram or ultrasound, with ultrasound being the preferred method of evaluation. Measurements by physical exam should also be recorded. If mammogram and ultrasound are discordant, then the imaging modality that determines the largest tumor size will be used to determine eligibility.
- Ultrasound measurements: Distance from tumor to skin must be \> 1 cm; distance from tumor to chest wall must be \> 1 cm. The RFA procedure, which burns the tumor, may also burn the skin or muscle if it is too close (\< 1cm).
- Laboratory values within 2 weeks of registration: platelet count ≥ 50,000; INR ≤ 1.6; serum creatinine ≤ 1.5 mg/dL; glomerular filtration rate (GFR) ≥ 60 ml/min/m\^2
- Age 18 years or older
- Women must not be pregnant due to MR scanning of pregnant women is not FDA approved. All females of childbearing potential must have a urine study within 2 weeks prior to registration to rule out. Breast feeding must be discontinued prior to study entry.
You may not qualify if:
- Subjects for whom neo-adjuvant therapy is planned will be excluded from this study
- Patients with history of severe asthma and/or allergies will be excluded to avoid potential adverse reactions to the MRI contrast agent (Gd-DTPA)
- Patients with pacemakers, any ferromagnetic implants or other ferromagnetic objects will be excluded
- Patients with obesity (\>250 pounds) will be excluded due to the limited diameter of the magnet bore tube
- Patients with history of severe claustrophobia will be excluded
- Patient must give written informed consent indicating the investigational nature of the study and its potential risks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Todd M. Tuttle, MD
Masonic Cancer Center, University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2006
First Posted
September 7, 2006
Study Start
March 1, 2005
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
December 5, 2017
Record last verified: 2017-12