Clinical trial NCT01929395: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Breast Conserving Surgery
Breast diagnostics
Breast imaging
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2013-08-27
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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:

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.

Eligibility 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

Primary outcomes:
measure: The Mean Distance Between the Image-defined and Palpation-defined Edges of the Tumor.
timeFrame: From baseline MRI to intraoperative measurements: 30 days
measure: 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.
timeFrame: 30 days from surgery
Secondary outcomes:
measure: Differences Between the Two Groups in the Volume of Breast Tissue Removed
timeFrame: 30 days from surgery
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
References: