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Stage I Breast CarcinomaNCT02057432

Image-guided Breast Surgery in the Advanced Multimodality Image Guided Operating Suite (AMIGO)

A study testing intra-operative MRI in people with Stage I Breast Carcinoma and Stage II Breast Carcinoma, run by Dana-Farber Cancer Institute at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research study is a pilot study designed to evaluate magnetic resonance imaging-guided therapy (MRT) as a possible treatment for breast cancer. In this pilot study, the investigators are studying if it is possible to use intra-operative MRI to guide surgery. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
intra-operative MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesUnited States
Study dates
Apr 2012to Aug 2016
Phase
Interventional
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have a pre-operative standard mammogram with or without ultrasound. These may be performed at outside institutions.
  • Participants must have biopsy confirmed invasive breast carcinoma. If biopsy was done at an outside hospital, pathology will be reviewed at BWH/DFCI.
  • Stage: Clinical Staging must be Stage I or II as outlined by the AJCC 7th edition. Pre-operative diagnosis of positive axillary nodes necessitating axillary dissection at the time of lumpectomy does not disqualify a patient.
  • Pre-operative sentinel node biopsy also does not disqualify the patient.
  • Participants must be candidates for definitive local therapy with breast conserving therapy (this takes into account tumor to breast size ratio appropriate for BCS, and the ability to undergo standard radiation therapy post-operatively).
  • Participants must have measurable disease, defined as one lesion that can be accurately measured by MRI. (More than one lesion will be an exclusion criteria for BCS; lesions not identified by MRI will also be an exclusion criteria).
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  • Age ≥ 18 years and < 75.
  • Completion of the magnetic resonance (MR) procedure screening form and clearance by the MR technologist that the patient does not have a pacemaker, brain aneurysm clip, inner ear implant, neurostimulator or metal fragments in the eye.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
  • Participants with a known BRCA 1 or 2 mutation.
  • Participants with known Li-Fraumeni or Cowden's Disease.
  • Participants with prior mantle radiation.
  • Participants with locally advanced breast cancer such as inflammatory breast cancer or cancer grossly involving skin.
  • Participants who are pregnant.
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  • Participants who enroll in a preoperative therapy trial or who have been treated with neoadjuvant chemotherapy. The neoadjuvant chemotherapy can result in complete pathologic response, resulting in no signal on MRI.
  • Participants with known, active collagen vascular disease.
  • Participants who undergo breast surgery at an outside institution.
  • Participants with prior history of breast carcinoma.
  • Patients who have implants or any type of breast reconstruction.
  • Patients who have biopsy confirmed multi-centric disease.
  • Participants who have documented contra-indications for MRI.
  • Participants who have documented allergic reaction to IV MRI contrast agent, or have a contraindication to the administration of IV contrast such as renal failure.
  • Patients with diabetes will be excluded because of a higher risk to incur renal damage from the IV contrast.
  • Participants who exceed the weight limit for the surgical table at AMIGO, 350 lbs or who will not fit into the 70 cm diameter bore of the MRI scanner at AMIGO or the 60 cm diameter bore of the pre-procedure imaging MRI scanner.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: A Pilot Study to Evaluate Image-guided Breast Conserving Surgery in the Advanced Multimodality Image Guided Operating Suite (AMIGO)

This research study is a pilot study designed to evaluate magnetic resonance imaging-guided therapy (MRT) as a possible treatment for breast cancer. In this pilot study, the investigators are studying if it is possible to use intra-operative MRI to guide surgery. The therapy takes place in the Advanced Multimodality Image Guided Operating (AMIGO) suite at Brigham and Women's Hospital.

The purpose of this study is to investigate if it is possible to perform the breast conserving surgery with the help of intra-operative magnetic resonance imaging in the advanced multimodality image guided operating suite. It is hoped that intra operative MRI may improve the surgeon's ability to know the exact margins of tumor. Currently, approximately 40% of women need to come back to the operating room and have the margins of the cancer re-excised.

Read the detailed description

The treatment being studied consists of standard lumpectomy and sentinel node biopsy if indicated, or standard axillary dissection if clinically indicated. The study includes the additional use of MRI to guide the removal of the cancer. The MRI uses powerful magnets linked to a computer to create detailed pictures of the breast. The purpose of the current study is to find out whether performing the intra-operative MRI is possible, safe and practical. As part of the study the participant will need to have tests to show that they are eligible to participate in the research study.If the participant does not meet the eligibility criteria, they will not be able to participate in this research study.

Surgery Day

  • Wire localization with ultrasound, Mammogram or MRI in the non-palpable tumor is placed in the participant's breast. The presence of the wire in the tumor will then help guide the surgeon to the location of the tumor.
  • The sentinel node biopsy or axillary dissection will be performed if indicated.
  • Then the lumpectomy will be performed.
  • The participant will undergo an intra-operative MRI scan in the AMIGO. ---If the MRI images indicate there may be tumor behind, more tissue will be removed from the respective margins. No additional MRIs will be performed.
  • Most of these operations are outpatient. However, the need to stay overnight may occur if the recovery from anesthesia is slow or if the participant underwent an axillary dissection.

Within six weeks after patient surgery. The participant will have the following procedures:

  • History and physical exam
  • Wound check
  • The participant will also be informed of the final pathology, including margin status.The remainder of follow up will be as per standard of care after breast conserving surgery for breast cancer. The participant will be assessed by physical exam for possible complications and local recurrence. These visits will likely overlap with established oncology care team follow-up visits.
Being tested
intra-operative MRI
Keywords
I-II 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.

  • intra-operative MRIDevice

    Patients will undergo an MRI during surgery.

Study groups in NCT02057432
Study groupRoleWhat they receive
Intra-operative MRIExperimentalImages will be obtained both before and after intravenous bolus injection with subsequent dynamic imaging. Dynamic contrast enhancement maps will be created for evaluation of residual tumor. Images will be reformatted into three orthogonal planes as well as into a 3D model for surgical orientation. All imaging protocols using contrast, contrast enhancement maps and reformatting, as described above, which will be applied to the intra-operative MRI performed in the AMIGO suite are consistent with the standard MRI breast imaging at Brigham and Women's Hospital.
Receives: Device: intra-operative MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To demonstrate feasibility of using the intra-operative MRI for breast conserving surgery

    For the purpose of this pilot study, feasibility is defined as the ability to successfully complete the breast conserving operation in the

    AMIGO suite. Feasibility must entail the following:

    All necessary instruments for this operation are MRI compatible or are able to be used safely and then stored outside of the magnetic field when the intra-operative MRI is performed. The intra-operative MRI is performed without compromising the sterile operative field.

    Measured: 2 Years

Secondary outcomes (4)

  1. Duration of the Lumpectomy and Imaging

    To measure duration of the lumpectomy portion of the procedure, the duration of the imaging portion of the procedure, and time under anesthesia.

    Measured: 2 Years

  2. Final Pathology Report and Intra-operative MRI Comparison

    The intra-operative MRI images will be compared to final pathology report which is the gold standard. This objective is for the purpose of collecting preliminary data for planning a future study which will be adequately powered to show the sensitivity and true positives of the intraoperative MRI.

    Measured: 2 Years

  3. Number of operations needed to obtain clear margins if clear margins were not obtained on initial operation.

    Number of operations needed to obtain clear margins if clear margins were not obtained on initial operation.

    Measured: 2 Years

  4. Volume of tissue removed on initial operation and on secondary operations if these were necessary.

    Volume of tissue removed on initial operation and on secondary operations if these were necessary.

    Measured: 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2014 (estimated)
  2. Study startApr 2012
  3. Primary completionJan 2016
  4. Study completionAug 2016

Resources

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 N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02057432
Sponsor's protocol ID
11-454
Status last verified
Jan 2017
First submitted
3 Jan 2014
Last updated
24 Jan 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing intra-operative MRI in people with Stage I Breast Carcinoma and Stage II Breast Carcinoma, run by Dana-Farber Cancer Institute at 2 sites in United States.

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 9 inclusion and 16 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: finished, as of the sponsor's last update on 24 Jan 2017. 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. 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.

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.

What does the primary outcome measure?

To demonstrate feasibility of using the intra-operative MRI for breast conserving surgery (time frame: 2 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02057432.

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 24 Jan 2017.

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