Breast CancerPhase 2NCT00373152
MRI in Predicting Tumor Reponse After Radiofrequency Ablation in Women With Invasive Breast Cancer
A Phase 2 study testing Lumpectomy, dynamic contrast-enhanced magnetic resonance imaging and radiofrequency ablation in people with Breast Cancer, run by Masonic Cancer Center, University of Minnesota.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Lumpectomy, dynamic contrast-enhanced magnetic resonance imaging and radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Breast MRI Assessment of Tumor Viability After Radiofrequency Ablation (RFA)
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.
Read the 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
- Being tested
- Lumpectomy, dynamic contrast-enhanced magnetic resonance imaging, radiofrequency ablation, gadopentetate dimeglumine
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumpectomyProcedure or surgery
Standard lumpectomy or mastectomy will be performed 1 to 21 days after the post-RFA MRI.
dynamic contrast-enhanced magnetic resonance imagingProcedure or surgery
Also called MRI
Dynamic-contrast enhanced breast images will be visualized with parametric image maps to assist in identifying regions with residual cancer.
radiofrequency ablationProcedure or surgery
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 dimeglumineRadiation
Also called contrast dye, Gd-DTPA
Injected at baseline MRI and post radiofrequency ablation MRI.
| Study group | Role | What they receive |
|---|---|---|
| RadioFrequency Ablation for Breast Cancer | Experimental | Not described Receives: Procedure: Lumpectomy; Procedure: dynamic contrast-enhanced magnetic resonance imaging; Procedure: radiofrequency ablation; Radiation: gadopentetate dimeglumine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: after RFA but before definitive surgery
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.
Measured: before definitive surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startMar 2005
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: No patient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Todd M. Tuttle, MD, Study chair, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373152
- Sponsor's protocol ID
- 2005LS006
- Other IDs
- UMN-0412M66271
- Status last verified
- Dec 2017
- First submitted
- 6 Sep 2006
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast MRI Assessment of Tumor Viability After Radiofrequency Ablation (RFA)
- ClinicalTrials.gov ID
- NCT00373152
- Acronym / sponsor ID
- 2005LS006
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patient accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 7 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RadioFrequency Ablation for Breast Cancer | Experimental | Procedure: Lumpectomy, Procedure: dynamic contrast-enhanced magnetic resonance imaging, Procedure: radiofrequency ablation, Radiation: gadopentetate dimeglumine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LumpectomyStandard lumpectomy or mastectomy will be performed 1 to 21 days after the post-RFA MRI. | Procedure or surgery | RadioFrequency Ablation for Breast Cancer |
| dynamic contrast-enhanced magnetic resonance imagingAlso: MRIDynamic-contrast enhanced breast images will be visualized with parametric image maps to assist in identifying regions with residual cancer. | Procedure or surgery | RadioFrequency Ablation for Breast Cancer |
| radiofrequency ablationRFA 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. | Procedure or surgery | RadioFrequency Ablation for Breast Cancer |
| gadopentetate dimeglumineAlso: contrast dye, Gd-DTPAInjected at baseline MRI and post radiofrequency ablation MRI. | Radiation | RadioFrequency Ablation for Breast Cancer |
Primary outcome
Complete Tumor Necrosis
Efficacy of radiofrequency ablation (RFA) in inducing complete tumor necrosis as measured by immunohistochemical and biomarker studies.
3 secondary outcomes
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
Time frame: after RFA but before definitive surgery
Toxicity or complications of RFA
Time frame: before definitive surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd M. Tuttle, MD study chair
Masonic Cancer Center, University of Minnesota
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lumpectomy, dynamic contrast-enhanced magnetic resonance imaging and radiofrequency ablation in people with Breast Cancer, run by Masonic Cancer Center, University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Tumor Necrosis. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.