N/A
N=57
Supine MRI in Breast Cancer Patients Undergoing Upfront Surgery or Receiving Neoadjuvant Therapy
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02956473 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Correlation Between Prone Breast MRI for Estimation of Tumor Size and Final Pathology Tumor Size — 0.635 correlation coefficient
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Supine MRI (Device); Neoadjuvant Therapy (NAT) (Other); Ultrasound (Device); Mammography (Device); Standard of Care (Procedure); Standard MRI (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Between Prone Breast MRI for Estimation of Tumor Size and Final Pathology Tumor Size |
0.635 | — |
| PRIMARY Correlation Between Supine Breast MRI for Estimation Of Tumor Size and The Pathologic Tumor Size |
0.652 | — |
| PRIMARY Correlation of Breast Tumor Dimensions Between Prone and Supine Imaging Positions. |
0.789 | — |
| SECONDARY The Perceived Benefit Of Supine MRI For Surgical Planning As Measured By The Collective Results Of A Survey Of Surgeons Performing Breast-conserving Therapy (BCT) In Our Study Patient Population |
0.43 | — |
Summary
This research study involves the use of a common breast imaging modality (magnetic resonance imaging, 'MRI') and is investigating its role in evaluating surgical decision making for breast cancer when it is performed with the patient in a new position (lying on one's back) as opposed to in the standard position (lying on one's stomach).
Eligibility Criteria
Inclusion Criteria
- Participants must be female
- Participants must have a pre-operative standard mammogram with or without ultrasound.
- Participants must have biopsy confirmed and clinical stage I, stage II, or stage III non-inflammatory breast carcinoma. If biopsy was done at an outside hospital, pathology will be reviewed at (BWH, BWFH)
- Patient must meet standard MRI guidelines and be able and willing to undergo MRI
- Participants must be candidates for definitive local therapy with breast conserving therapy or deemed as potential candidates following NAT (this takes into account tumor to breast size ratio appropriate for BCT, and the ability to undergo standard radiation therapy post-operatively).
- Study participants will be restricted to those aged ≥18 years old. This age group is selected because it encompasses the majority of women likely to receive neoadjuvant therapy
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
- Participants with a known BRCA 1 or 2 mutation.
- Participants with a known Li-Fraumeni or Cowden's Disease.
- Participants with prior mantle radiation.
- Participants with inflammatory breast cancer or multi-centric disease
- Participants who are pregnant.
- Participants who are already enrolled in a conflicting investigational trial
- Participants with known active collagen vascular disease.
- Participants with prior history of ipsilateral breast carcinoma treated with BCS and radiation therapy.
- Patients who have biopsy confirmed multi-centric disease.
- Participants who are unable to undergo MRI because of documented contra-indications for contrast-enhanced MRI, including but not limited to renal failure
- Participants who exceed the weight limit for the operative surgical table, 350 lbs or who will not fit into the 60 cm diameter bore of the MRI scanner.
Data sourced from ClinicalTrials.gov (NCT02956473). 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.