N/A
N=23
A Study to Evaluate the Accuracy of a Breast Cancer Locator (BCL) in Patients With Palpable Cancers
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02550210 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: The Distance Measured by Pathology From the Tumor Edge to the Center of the Ink Spots, as Marked by the Black Inked Pins. — 1.7 cm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Breast Cancer Locator (BCL) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Distance Measured by Pathology From the Tumor Edge to the Center of the Ink Spots, as Marked by the Black Inked Pins. |
1.7 | — |
| SECONDARY Positive Margin Rate |
— | — |
| SECONDARY The Distances Between the Specimen Edges as Determined by the Breast Cancer Locator and by the Supine MRI/Optical Scan/ Tracker System |
0.33 | — |
| SECONDARY Mean Resection Specimen Volume |
116 | — |
Summary
In this study, the investigators will enroll women with palpable cancers to assess the accuracy of the Breast Cancer Locator (BCL) and the concomitant procedure as a vehicle to optimize and validate the approach in such surgical cases. This approach of adopting palpable cancer patients before initiating an evaluative trial of the BCL in non-palpable breast cancer cases ensures that the BCL does not substantially alter or modify the standard-of-care procedure.
Eligibility Criteria
Inclusion Criteria
- Age greater than or equal to 18 years
- Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ
- Patient desire to undergo breast surgery
- Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted
- The cancer enhances on breast MRI imaging.
Exclusion Criteria
- 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 policy for MRIs at DHMC.
Data sourced from ClinicalTrials.gov (NCT02550210). 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.