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A Study to Evaluate the Use of Supine MRI Images in Breast Conserving Surgery

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ClinicalTrials.gov Identifier: NCT01929395
Recruitment Status : Completed
First Posted : August 27, 2013
Results First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center

Brief Summary:
This is a 2 Phase study. In the first phase of the study, patients with palpable invasive breast cancer underwent pre-operative supine MRI and optical scanning in the surgical position. In the second phase of the study, patients with non-palpable invasive breast cancer or DCIS who desire breast conservation will be randomized to either a usual care group, or a group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI) and undergoing breast cancer resection without the wire localization technique.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Supine MRI Not Applicable

Detailed Description:

We propose to use a novel technique (optical scanning) to correlate the supine MRI image to the surgical position in the OR and then to confirm and extend the Japanese study described above. In the first phase of the study, 5-25 patients with palpable invasive breast cancer will undergo pre-operative supine MRI and optical scanning in the surgical position. The purpose of this phase will be ensure that the images created from the optical scanner-adjusted supine MRI images closely correspond to the location of the palpable tumors in these breasts. All patients will then have their tumor resected using the standard method of either palpation or image guided wire localization. The first phase has been completed.

In the second phase of the study, patients with non-palpable invasive breast cancer or DCIS who desire breast conservation will be randomized to either a usual care group, or a group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI) and undergoing breast cancer resection without the wire localization technique.

Our secondary objectives will be to determine:

  1. whether there are differences between the two groups in the volume of breast tissue removed.
  2. whether diagnostic information obtained from a supine MRI is equivalent to that obtained from the prone MRI.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Study to Evaluate the Use of Supine MRI Images in Breast Conserving Surgery
Actual Study Start Date : September 2009
Actual Primary Completion Date : March 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm 1 addition of supine MRI to conventional imaging
Arm 1 objective will be to determine whether the addition of supine MRI to conventional imaging with mammography and or sonography and prone MRI will result in a lower positive margin rate in patients undergoing breast conserving surgery.
Device: Supine MRI
A limitation of MRI studies of the breast is that MRI exams are performed with the patient prone and the breasts in a pendant position, which is markedly different than the position of the breast when the patient is supine on the Operating Room table. The spatial information the surgeon receives from the prone MRI about the site of the tumor in the breast is hard to mentally translate into the actual site of the tumor in the breast of a supine patient prepared for surgery.

Active Comparator: Arm 2 randomize to SOC vs supine MRI + SOC
Arm 2 of the study patients with non-palpable invasive breast cancer or DCIS who desire breast conservation will be randomized to either a usual care group, or a group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI) and undergoing breast cancer resection without the wire localization technique.
Device: Supine MRI
A limitation of MRI studies of the breast is that MRI exams are performed with the patient prone and the breasts in a pendant position, which is markedly different than the position of the breast when the patient is supine on the Operating Room table. The spatial information the surgeon receives from the prone MRI about the site of the tumor in the breast is hard to mentally translate into the actual site of the tumor in the breast of a supine patient prepared for surgery.




Primary Outcome Measures :
  1. The Mean Distance Between the Image-defined and Palpation-defined Edges of the Tumor. [ Time Frame: From baseline MRI to intraoperative measurements: 30 days ]
    Mean calculated from differences in precise distances from the nipple to the superior, inferior, medial and lateral edges of the tumor as determined from the adjusted MRI images and conventional MRI.

  2. To Determine Whether the Addition of Supine MRI to Conventional Imaging With Mammography and Prone MRI Results in a Lower Positive Margin Rate in Patients Undergoing Breast-conserving Surgery. [ Time Frame: 30 days from surgery ]
    The primary analysis consists of computing the positive margin rate observed in the two groups and comparing them with a chi-squared test and finally comparing the proportion of patients with positive margins in the two groups based on study criteria.


Secondary Outcome Measures :
  1. Differences Between the Two Groups in the Volume of Breast Tissue Removed [ Time Frame: 30 days from surgery ]
    The mean specimen volumes to be compared using t - statistics. The concordance between lesion volumes identified on the supine MRI images and the prone MRI images will be evaluated through correlation and regression analysis.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria Phase 1

  1. Age greater than/equal to 18 years
  2. Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ
  3. Patient desire to undergo breast surgery

3. Patients will have provided informed consent to participate, documented by their signature on the study consent form 4. The cancer enhances on breast MRI imaging.

Inclusion Criteria Phase 2

  1. Age greater than/equal to 18 years
  2. Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ
  3. The tumor is visible and enhances on prone MRI and is >1 cm in greatest diameter.
  4. . Determination by the surgeon that the neoplasm is non-palpable.A patient with a palpable hematoma from core biopsy, but a non-palpable neoplasm, will be eligible for study
  5. Patient desire to undergo breast conserving surgery
  6. Patients will have provided informed consent to participate, documented by their signature on the study consent form.The process of informed consent will be documented in the medical record and a copy of the signed consent form will be given to the patient.

Exclusion Criteria (Phases 1 and 2)

  1. Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip or metallic foreign body in or near eyes
  2. Severe claustrophobia
  3. Contraindication to use of gadolinium based intravenous contrast, including life threatening allergy or compromised renal function (creatinine > 2.0)
  4. History of median sternotomy
  5. Pregnancy (Patient attestation that they are not pregnant will be acceptable, as per standard, as per standard policy for MRIs at DHMC).
  6. Multicentric breast cancer, defined as two or more tumors in different quadrants of the breast. An eligibility worksheet will be completed for each patient prior to enrollment and will be signed and dated by the surgeon investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929395


Locations
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United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
  Study Documents (Full-Text)

Documents provided by Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center:
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Responsible Party: Richard J. Barth,Jr., Section Chief, General Surgery, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01929395    
Other Study ID Numbers: D0928
NCI-2011-03481 ( Other Identifier: NCI )
First Posted: August 27, 2013    Key Record Dates
Results First Posted: April 30, 2019
Last Update Posted: April 30, 2019
Last Verified: April 2019
Keywords provided by Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center:
Breast Cancer
Breast Conserving Surgery
Breast diagnostics
Breast imaging
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases