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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Supine MRI

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer, Breast Conserving Surgery, Breast diagnostics, Breast imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Phase 1

Age greater than/equal to 18 years
Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ
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

Age greater than/equal to 18 years
Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ
The tumor is visible and enhances on prone MRI and is >1 cm in greatest diameter.
. 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
Patient desire to undergo breast conserving surgery
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)

Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip or metallic foreign body in or near eyes
Severe claustrophobia
Contraindication to use of gadolinium based intravenous contrast, including life threatening allergy or compromised renal function (creatinine > 2.0)
History of median sternotomy
Pregnancy (Patient attestation that they are not pregnant will be acceptable, as per standard, as per standard policy for MRIs at DHMC).
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

Sites / Locations

Dartmouth Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm 1 addition of supine MRI to conventional imaging

Arm 2 randomize to SOC vs supine MRI + SOC

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The Mean Distance Between the Image-defined and Palpation-defined Edges of the Tumor.

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.

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.

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

Differences Between the Two Groups in the Volume of Breast Tissue Removed

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.

Full Information

NCT ID

NCT01929395

First Posted

April 5, 2013

Last Updated

April 8, 2019

Sponsor

Dartmouth-Hitchcock Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01929395

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

September 2009 (Actual)

Primary Completion Date

March 2018 (Actual)

Study Completion Date

July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast Cancer, Breast Conserving Surgery, Breast diagnostics, Breast imaging

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

159 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1 addition of supine MRI to conventional imaging

Arm Type

Active Comparator

Arm Description

Arm Title

Arm 2 randomize to SOC vs supine MRI + SOC

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Supine MRI

Intervention Description

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 Measure Information:

Title

The Mean Distance Between the Image-defined and Palpation-defined Edges of the Tumor.

Description

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.

Time Frame

From baseline MRI to intraoperative measurements: 30 days

Title

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.

Description

Time Frame

30 days from surgery

Secondary Outcome Measure Information:

Title

Differences Between the Two Groups in the Volume of Breast Tissue Removed

Description

Time Frame

30 days from surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Phase 1 Age greater than/equal to 18 years Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ 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 Age greater than/equal to 18 years Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ The tumor is visible and enhances on prone MRI and is >1 cm in greatest diameter. . 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 Patient desire to undergo breast conserving surgery 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) Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip or metallic foreign body in or near eyes Severe claustrophobia Contraindication to use of gadolinium based intravenous contrast, including life threatening allergy or compromised renal function (creatinine > 2.0) History of median sternotomy Pregnancy (Patient attestation that they are not pregnant will be acceptable, as per standard, as per standard policy for MRIs at DHMC). 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

Facility Information:

Facility Name

Dartmouth Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

12. IPD Sharing Statement

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

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