Breast CancerPhase 2NCT00008437
MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer
A Phase 2 study testing high-intensity focused ultrasound ablation in people with Breast Cancer, run by InSightec at 2 sites in 2 countries.
Trial summary
RATIONALE: Imaging procedures, such as MRI, may allow the doctor to better detect the tumor. Highly focused ultrasound energy may be able to kill tumor cells by heating the breast tumor cells without affecting the surrounding tissue. 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?
- high-intensity focused ultrasound ablation
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2000to Dec 2000
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer (T1, N0-2, M0)
- Single focal lesion no greater than 3.5 cm in diameter by MRI
- No lesions difficult to target, defined as less than 1 cm from skin, nipple, or rib cage
- No microcalcifications as sole sign of disease
- No extensive intraductal components on core biopsy, defined as intraductal carcinoma comprising 25% or more of the invasive breast cancer AND intraductal carcinoma in surrounding normal tissue
- No breast implants
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Karnofsky 80-100%
Life expectancy:
- At least 5 years
Hematopoietic:
- No hemolytic anemia (hematocrit less than 30%)
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- No heart disease
- No unstable angina pectoris requiring medication
- No myocardial infarction within the past 6 months
- No congestive heart failure requiring medication
- No diastolic blood pressure greater than 100 mm Hg while receiving medication to treat hypertension
- No cerebrovascular accident (CVA) within the past 6 months
- No multiple CVAs
- No cardiac pacemakers
Pulmonary:
- No chronic obstructive pulmonary disease
- No other lung disease
- No sleep apnea or airway problems
- No severe asthma
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No contraindications to MRI (e.g., implanted medical devices)
- Must be able to lie prone and still for up to 150 minutes
- Weight no greater than 250 pounds
- No severe arthritis
- No severe claustrophobia
- No grand mal seizures
- No insulin-dependent diabetes mellitus
- No prior reaction to gadolinium-based contrast agent
- Able to communicate sensations during procedure
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 3 months since prior chemotherapy
Endocrine therapy:
- Concurrent hormone replacement therapy allowed
- Concurrent tamoxifen allowed
- No concurrent steroids
Radiotherapy:
- No prior external radiotherapy or laser therapy to ipsilateral breast
Surgery:
- See Disease Characteristics
Other:
- No concurrent anti-arrhythmic drugs
- No concurrent immunosuppressive medication
- No concurrent anticoagulation therapy
- No concurrent dialysis
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
About this study
Official title: Pilot Study of MR-Guided Focused Ultrasound for Tissue Coagulation in Women With Breast Cancer: MR Imaging and Histopathic Correlation, An Assessment or Target Accuracy and Patient Acceptance
RATIONALE: Imaging procedures, such as MRI, may allow the doctor to better detect the tumor. Highly focused ultrasound energy may be able to kill tumor cells by heating the breast tumor cells without affecting the surrounding tissue.
PURPOSE: Phase II trial to study the effectiveness of MRI-guided ultrasound energy in treating women who have stage I, stage II, or stage IIIA breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the incidence and severity of adverse events during and after MRI-guided focused ultrasound ablation in women with stage I-IIIA breast cancer.
- Determine the ability to accurately and thoroughly coagulate a target volume of breast carcinoma, in terms of real-time target volume temperature profile, follow-up MRI, and histology, using this procedure.
- Compare the appearance of gross and microscopic histopathologic tissue post coagulation with the pre- and post-coagulation magnetic resonance appearance of the targeted volume and measure any residual cancer cells in patients after this procedure.
- Determine patient acceptance of this procedure, in terms of positioning, pain, safety, and follow-up cosmesis.
OUTLINE: This is a pilot study.
Patients undergo MRI-guided focused ultrasound (MRgFUS) ablation of the breast lesion using a series of pulses. Within 72 hours after MRgFUS procedure, patients undergo gadolinium-enhanced MRI to evaluate ablation borders. Within 7-10 days after MRgFUS procedure, patients undergo an ultrasound exam. Guide wires may be placed to assist in pre-surgical lesion localization. Within 10-21 days after MRgFUS procedure, patients undergo segmental resection or mastectomy.
Patients are followed at 5-10 days post-surgery.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- high-intensity focused ultrasound ablation
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA 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.
high-intensity focused ultrasound ablationDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startDec 2000
- Primary completionDec 2000
- Study completionDec 2000
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 InSightecThe 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
- Treatment
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert W. Newman, Study chair, InSightec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00008437
- Sponsor's protocol ID
- CDR0000068417
- Other IDs
- TXS-G990184, DFCI-99029, MDA-ID-99137, TXS-1999-P-009925/10, NCI-V00-1643
- Status last verified
- Jun 2012
- First submitted
- 6 Jan 2001
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of MR-Guided Focused Ultrasound for Tissue Coagulation in Women With Breast Cancer: MR Imaging and Histopathic Correlation, An Assessment or Target Accuracy and Patient Acceptance
- ClinicalTrials.gov ID
- NCT00008437
- Acronym / sponsor ID
- CDR0000068417
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- Dec 2000
- Primary completion
- Dec 2000 (actual)
- Study completion
- Dec 2000 (actual)
- First posted
- 27 Jan 2003 (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: Imaging procedures, such as MRI, may allow the doctor to better detect the tumor. Highly focused ultrasound energy may be able to kill tumor cells by heating the breast tumor cells without affecting the surrounding tissue.
PURPOSE: Phase II trial to study the effectiveness of MRI-guided ultrasound energy in treating women who have stage I, stage II, or stage IIIA breast cancer.
Detailed description
OBJECTIVES:
- Determine the incidence and severity of adverse events during and after MRI-guided focused ultrasound ablation in women with stage I-IIIA breast cancer.
- Determine the ability to accurately and thoroughly coagulate a target volume of breast carcinoma, in terms of real-time target volume temperature profile, follow-up MRI, and histology, using this procedure.
- Compare the appearance of gross and microscopic histopathologic tissue post coagulation with the pre- and post-coagulation magnetic resonance appearance of the targeted volume and measure any residual cancer cells in patients after this procedure.
- Determine patient acceptance of this procedure, in terms of positioning, pain, safety, and follow-up cosmesis.
OUTLINE: This is a pilot study.
Patients undergo MRI-guided focused ultrasound (MRgFUS) ablation of the breast lesion using a series of pulses. Within 72 hours after MRgFUS procedure, patients undergo gadolinium-enhanced MRI to evaluate ablation borders. Within 7-10 days after MRgFUS procedure, patients undergo an ultrasound exam. Guide wires may be placed to assist in pre-surgical lesion localization. Within 10-21 days after MRgFUS procedure, patients undergo segmental resection or mastectomy.
Patients are followed at 5-10 days post-surgery.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| high-intensity focused ultrasound ablation | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
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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.
Robert W. Newman study chair
InSightec
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing high-intensity focused ultrasound ablation in people with Breast Cancer, run by InSightec at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 2 Jul 2012.