A Pilot Multi-Institutional Study to Evaluate the Accuracy of a Breast Cancer Locator in Patients With Palpable Cancers
Completed · Not applicable
Conditions studied: Palpable Breast Cancer
In brief
The project objective is to determine whether the Breast Cancer Locator (BCL) can safely and effectively localize breast cancers in patients treated at locations distant from the site of BCL manufacture. This information will be transmitted to CairnSurgical, Inc. where the BCL will be fabricated, tested for quality assurance, sterilized and shipped to the patient's surgeon. The surgeon will then utilize the BCL at the time of resection of the palpable breast cancer.
Key facts
- Study ID
- NCT03573661
- Run by
- Dartmouth-Hitchcock Medical Center
- People needed
- 18
- Starts
- 2018-05-24
- Expected to finish
- 2021-04-05
- Last updated by the study team
- 2021-05-25
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Age > 18 years.
- Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ.
- Patient desire to undergo breast surgery (lumpectomy or non-skin sparing mastectomy).
- Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.
- The cancer enhances on prone breast MRI imaging
- The cancer is visible on mammography.
You may not qualify if…
- 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.
- Patients receiving neoadjuvant chemotherapy.
Where it is running
- Lahey Hospital & Medical Center (Lahey Clinic) — Burlington, Massachusetts, United States
- Cheshire Medical Center — Keene, New Hampshire, United States
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
- St. Joseph Hospital — Nashua, New Hampshire, United States
Full record on ClinicalTrials.gov
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