N/A
N=159
A Study to Evaluate the Use of Supine MRI Images in Breast Conserving Surgery
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01929395 ↗Enrolled (actual)
159
Serious AEs
1.3%
Results posted
Apr 2019
Primary outcome: Primary: The Mean Distance Between the Image-defined and Palpation-defined Edges of the Tumor. — 7.2 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Supine MRI (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Distance Between the Image-defined and Palpation-defined Edges of the Tumor. |
7.2 | — |
| PRIMARY 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. |
8; 16 | — |
| SECONDARY Differences Between the Two Groups in the Volume of Breast Tissue Removed |
74; 69.8 | — |
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.
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
- 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
Data sourced from ClinicalTrials.gov (NCT01929395). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.