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

This study has been withdrawn prior to enrollment.
(No patient accrual)
Sponsor:
Information provided by:
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00373152
First received: September 6, 2006
Last updated: August 11, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Procedure: Lumpectomy
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Procedure: radiofrequency ablation
Radiation: gadopentetate dimeglumine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Breast MRI Assessment of Tumor Viability After Radiofrequency Ablation (RFA)

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Complete Tumor Necrosis [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
  • Cosmetic Outcome [ Time Frame: after RFA but before definitive surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: before definitive surgery ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 0
Study Start Date: March 2005
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RadioFrequency Ablation for Breast Cancer Procedure: Lumpectomy
Standard lumpectomy or mastectomy will be performed 1 to 21 days after the post-RFA MRI.
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.
Other Name: MRI
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.
Radiation: gadopentetate dimeglumine
Injected at baseline MRI and post radiofrequency ablation MRI.
Other Names:
  • contrast dye
  • Gd-DTPA

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373152

Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Study Chair: Todd M. Tuttle, MD Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Todd M. Tuttle, MD, Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00373152     History of Changes
Other Study ID Numbers: 2005LS006, UMN-0412M66271
Study First Received: September 6, 2006
Last Updated: August 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Masonic Cancer Center, University of Minnesota:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIC breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gadolinium DTPA
Gadobenic acid
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014