MRI in Predicting Tumor Reponse After Radiofrequency Ablation in Women With Invasive Breast Cancer

NCT ID: NCT00373152

Last Updated: 2017-12-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2010-06-30

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.

Detailed Description

OBJECTIVES:

Primary

• Determine if radiofrequency ablation (RFA) can induce complete tumor necrosis in women with invasive breast cancer.

Secondary

• Determine whether breast MRI can accurately predict residual cancer and tumor necrosis in patients treated with RFA.
• Determine the toxicity of RFA in these patients.
• Determine the cosmetic outcome after RFA in these patients.

OUTLINE: This is a prospective, nonrandomized study.

Patients undergo dynamic contrast-enhanced MRI (DCE-MRI) using gadopentetate dimeglumine. Within the next few days, patients undergo radiofrequency ablation (RFA) over approximately 20-30 minutes. Patients then undergo a second DCE-MRI 3 to 21 days after RFA, followed by definitive surgery (standard mastectomy or lumpectomy).

Pathologic confirmation of the post-ablation DCE-MRI findings is performed within 1 to 21 days after the second MRI. Tumor cell viability and proliferative activity are assessed by immunohistochemical and biomarker analysis.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIC breast cancer; stage IV breast cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

RadioFrequency Ablation for Breast Cancer

Group Type: EXPERIMENTAL

Lumpectomy

Intervention Type: PROCEDURE

Standard lumpectomy or mastectomy will be performed 1 to 21 days after the post-RFA MRI.

dynamic contrast-enhanced magnetic resonance imaging

Intervention Type: PROCEDURE

Dynamic-contrast enhanced breast images will be visualized with parametric image maps to assist in identifying regions with residual cancer.

radiofrequency ablation

Intervention Type: PROCEDURE

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.

gadopentetate dimeglumine

Intervention Type: RADIATION

Injected at baseline MRI and post radiofrequency ablation MRI.

Interventions

Lumpectomy

Standard lumpectomy or mastectomy will be performed 1 to 21 days after the post-RFA MRI.

Intervention Type: PROCEDURE

dynamic contrast-enhanced magnetic resonance imaging

Dynamic-contrast enhanced breast images will be visualized with parametric image maps to assist in identifying regions with residual cancer.

Intervention Type: PROCEDURE

radiofrequency ablation

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.

Intervention Type: PROCEDURE

gadopentetate dimeglumine

Injected at baseline MRI and post radiofrequency ablation MRI.

Intervention Type: RADIATION

Other Intervention Names

MRI; contrast dye; Gd-DTPA

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Todd M. Tuttle, MD

Role: STUDY_CHAIR

Masonic Cancer Center, University of Minnesota

Countries

United States

Other Identifiers

UMN-0412M66271

Identifier Type: OTHER

Identifier Source: secondary_id

2005LS006

Identifier Type: -

Identifier Source: org_study_id