Intraoperative Use of ClearEdge Device in Breast Conserving Surgery
Status unconfirmed · Not applicable
Conditions studied: Breast Cancer
In brief
Multi center, pivotal prospective, randomized clinical trial The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge imaging device to the Standard of Care (SoC) of margins assessment in breast conserving surgeries. The study will assess whether there is an improvement in the detection of DCIS or invasive cancer involved margins by measuring whether removal at the time of primary surgical treatment can reduce the need for repeat surgeries as compared to the SoC, which does not use the device.
Key facts
- Study ID
- NCT05456373
- Run by
- LS BioPath
- People needed
- 288
- Starts
- 2022-10-10
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2023-03-22
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patients who are female (genotype)
- Patients aged above 18 years, inclusive
- Patients diagnosed with breast DCIS or invasive cancer recommended for lumpectomy procedure
- Patients treated with neoadjuvant endocrine therapy may be enrolled
You may not qualify if…
- Patients currently receiving chemotherapy
- Patients having prior ipsilateral surgical treatment for breast cancer
- Patients who have had radiation therapy for ipsilateral breast cancer or for other malignancy that includes breast tissue in the radiation field (e.g. Hodgkin's lymphoma)
- Patients who have breast implants
- Patients who are pregnant and/or lactating
- Patients participating in other breast cancer studies involving surgical treatment to the breast in the past 6 months.
Where it is running
- UCSF Medical Center at Mission Bay — San Francisco, California, United States (enrolling)
Full record on ClinicalTrials.gov
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