Clinical trial NCT00373152: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIC breast cancer
stage IV breast cancer
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2006-09-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Complete Tumor Necrosis
Secondary outcomes:
measure: Sensitivity and specificity of delayed dynamic contrast-enhanced MRI (DCE-MRI) in detecting residual cancer after RFA as measured by the Hylton method
measure: Cosmetic Outcome
timeFrame: after RFA but before definitive surgery
measure: Toxicity or complications of RFA
timeFrame: before definitive surgery
Other outcomes:
Locations:
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Todd M. Tuttle, MD
role: STUDY_CHAIR
References: