Breast Cancer
Conditions
Brief summary
To learn if Pegulicianine Fluorescence-Guided Surgery (pFGS), which is part of the Lumicell Direct Visualization System, and Digital Breast Tomosynthesis (DBT) can improve the identification of tumor margins during a partial mastectomy and decrease the need for a second surgery.
Detailed description
Primary Objectives: -To determine if surgeon interpretation of pFGS and DBT has a higher specificity compared to SEP, resulting in fewer excisions of additional tissue unnecessarily Secondary Objectives: * To determine if surgeon evaluation of segmental mastectomy margins using pFGS and DBT is associated with better patient- and physician-reported cosmesis * To determine if surgeon interpretation of pFGS and DBT results in a lower rate of positive margins after BCS compared to SEP * To determine if surgeon interpretation of pFGS and DBT has a shorter operative time compared to SEP. * To determine if surgeon interpretation of pFGS and DBT results in less delays in receipt of adjuvant treatment and the reduction of targeted volume of radiation therapy or omission of radiation altogether
Interventions
PROCEDUREPegulicianine Fluorescence-Guided Surgery
Given by Surgery
PROCEDUREDigital Breast Tomosynthesis
Given by Procedure
PROCEDUREBreast Conserving Therapy
Given by Procedure
Sponsors
M.D. Anderson Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* We plan to enroll 175 patients. * Women aged 18 years or older with a breast cancer diagnosis at any stage who will undergo a segmental mastectomy, regardless of receipt of neoadjuvant therapy.
Exclusion criteria
1. Multi-site segmental mastectomies within the same breast 2. Participants without a cancer diagnosis 3. Participants from vulnerable populations including minors, pregnant women, and/or cognitively impaired adults.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and adverse events (AEs). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0 | Through study completion; an average of 1 year. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFedra Fallahian, MD
M.D. Anderson Cancer Center
Outcome results
None listed