Computed Optical Margin Assessment for Breast Cancer Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2015 |
| Start Date: | November 2012 |
| Contact: | Karyn Rhyder, RN |
| Email: | kriedal1@jhmi.edu |
| Phone: | 410-502-9693 |
This study is a multi-center, prospective, open label study of approximately fifty (50)
subjects at two (2) study sites, Johns Hopkins Hospital and Anne Arundel Medical Center.
Patients scheduled to undergo lumpectomy will be recruited by the clinical investigators at
the investigational site in accordance with the inclusion and exclusion criteria. The study
period per subject is the time it takes to assess the ex vivo breast tissue samples using
the study device during their lumpectomy.
This trial compares intraoperative imaging analysis of breast tumor margins to results from
post-operative histology. The study will evaluate the ability to identify margin status
(sensitivity and specificity) of intraoperative imaging vs. final pathology.
subjects at two (2) study sites, Johns Hopkins Hospital and Anne Arundel Medical Center.
Patients scheduled to undergo lumpectomy will be recruited by the clinical investigators at
the investigational site in accordance with the inclusion and exclusion criteria. The study
period per subject is the time it takes to assess the ex vivo breast tissue samples using
the study device during their lumpectomy.
This trial compares intraoperative imaging analysis of breast tumor margins to results from
post-operative histology. The study will evaluate the ability to identify margin status
(sensitivity and specificity) of intraoperative imaging vs. final pathology.
Inclusion Criteria:
1. Women 18 years of age or older
2. Signed informed consent form
3. Women who have been histologically diagnosed with invasive ductal carcinoma or
invasive lobular carcinoma of the breast prior to surgery
4. Patients planning breast preservation and undergoing lumpectomy (partial mastectomy)
procedure
Exclusion Criteria:
1. Multicentric disease (histologically diagnosed cancer in two different quadrants of
the breast)
2. Neoadjuvant systemic therapy
3. All T4 tumors
4. Previous radiation in the operated breast
5. Prior surgical procedure in the same quadrant
6. Implants in the operated breast
7. Pregnancy
8. Lactation
9. Participating in any other investigational study for either drug or device which can
influence collection of valid data under this study
We found this trial at
2
sites
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