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

Primary Purpose

Breast Cancer

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Lumpectomy

dynamic contrast-enhanced magnetic resonance imaging

radiofrequency ablation

gadopentetate dimeglumine

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIC breast cancer, stage IV breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RadioFrequency Ablation for Breast Cancer

Arm Description

Outcomes

Primary Outcome Measures

Complete Tumor Necrosis

Efficacy of radiofrequency ablation (RFA) in inducing complete tumor necrosis as measured by immunohistochemical and biomarker studies.

Secondary Outcome Measures

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

as rated by EORTC QLQ-C30. The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The rating system includes evaluation of breast size and shape, skin tone, nipple shape and location, appearance of the surgical scar, and overall cosmetic results. With the exception of evaluation of the surgical scar, all ratings are based on a comparison of the treated breast with the untreated breast. Patients will also rate the cosmetic outcome as excellent-good-fair-poor.

Toxicity or complications of RFA

as assessed by CTCAE v3.0 (Common Toxicity Criteria for Adverse Events, version 3.0). Any complications of RFA will be determined and documented before definitive surgery. Anticipated complications may include bleeding, pain, infection, and skin and chest muscle burns.

Full Information

NCT ID

NCT00373152

First Posted

September 6, 2006

Last Updated

December 3, 2017

Sponsor

Masonic Cancer Center, University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT00373152

Brief Title

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

Official Title

Breast MRI Assessment of Tumor Viability After Radiofrequency Ablation (RFA)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Withdrawn

Why Stopped

No patient accrual

Study Start Date

March 2005 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Masonic Cancer Center, University of Minnesota

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RadioFrequency Ablation for Breast Cancer

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Lumpectomy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

dynamic contrast-enhanced magnetic resonance imaging

Other Intervention Name(s)

MRI

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

radiofrequency ablation

Intervention Description

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

Radiation

Intervention Name(s)

gadopentetate dimeglumine

Other Intervention Name(s)

contrast dye, Gd-DTPA

Intervention Description

Injected at baseline MRI and post radiofrequency ablation MRI.

Primary Outcome Measure Information:

Title

Complete Tumor Necrosis

Description

Efficacy of radiofrequency ablation (RFA) in inducing complete tumor necrosis as measured by immunohistochemical and biomarker studies.

Secondary Outcome Measure Information:

Title

Sensitivity and specificity of delayed dynamic contrast-enhanced MRI (DCE-MRI) in detecting residual cancer after RFA as measured by the Hylton method

Title

Cosmetic Outcome

Description

Time Frame

after RFA but before definitive surgery

Title

Toxicity or complications of RFA

Description

Time Frame

before definitive surgery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Todd M. Tuttle, MD

Organizational Affiliation

Masonic Cancer Center, University of Minnesota

Official's Role

Study Chair

12. IPD Sharing Statement

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

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