Breast Cancer, Neoadjuvant Therapy
Conditions
Keywords
breast cancer surgery, lumpectomy
Brief summary
This is a prospective, multi-center, randomized, clinical trial evaluating patients undergoing breast conserving surgery using the LUM Imaging System.
Detailed description
Detailed Description: All subjects will be injected with LUM015. The injection of the study drug will occur 2-6 hours prior to surgery at a dose of 1.0 mg/kg. For all subjects, surgeons will perform main specimen resection per standard of care. For subjects randomized to the intervention arm, the surgeon will use the Lum System to scan and image all orientations within the cavity and The LUM Imaging System will guide shave removal. Then, for all subjects (control and intervention arm), comprehensive shaved margins are removed. In this study, the initial cohort is a training set with 10 patients receiving neoadjuvant therapy to refine the tumor detection algorithm, if needed. After completion of enrollment of the initial 10 subjects for algorithm training, the Investigators will then enroll a cohort of patients who received neoadjuvant therapy to further evaluate the performance of the LUM Imaging System in this important subset of breast cancer patients. Concurrently to the enrollment of this cohort, surgeons will also enroll a cohort of patients who did not receive neoadjuvant therapy prior to surgery. Patients will be randomized 3:1 to a LUM-assisted lumpectomy versus a standard lumpectomy. In both arms, shaved margins will be taken from the entire lumpectomy cavity to compare the extent of residual tumor after standard and LUM-assisted lumpectomies to evaluate the negative predictive value of the LUM Imaging System following neoadjuvant therapy. Only the group of patients randomized to the device (intervention) arm will have the LUM Imaging System guide the removal of tissue prior to the removal of final comprehensive shaves of the entire cavity. Study treatment ends when the surgery is completed. Patients are followed for adverse events until their standard of care follow-up visit or after any secondary surgery, whichever is longer.
Interventions
DRUGLUM015
LUM015 will be administered 2 to 6 hours prior to surgery for both arms. The LUM Imaging device will be used to assist in the removal of additional tumor tissue in the device intervention arm.
DEVICELum Imaging System
UM015 will be administered 2 to 6 hours prior to surgery for both arms. The LUM Imaging device will be used to assist in the removal of additional tumor tissue in the device intervention arm.
Sponsors
National Cancer Institute (NCI)
Lumicell, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Masking description
Masking will only be applied until main lumpectomy is removed. At time of randomization, the study arm will be revealed to the study team.
Intervention model description
Subjects will be randomized to receive the device intervention. All subjects will receive the study drug.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have histologically or cytologically confirmed primary invasive breast cancer, ductal carcinoma in situ (DCIS) or primary invasive breast cancer with a DCIS component. * Female, age of 18 years or older. * Subjects must have received neoadjuvant therapy for this breast cancer diagnosis prior to their lumpectomy procedure (cohorts 1 and 2). * Subjects must be scheduled for a lumpectomy for a breast malignancy. * Subjects must be able and willing to follow study procedures and instructions. * Subjects must have received and signed an informed consent form. * Subjects must have no uncontrolled serious medical problems except for the diagnosis of cancer, as per the
Exclusion criteria
listed below. * Leukocytes \> 1,000/mcL * Platelets \> 50,000/mcL * total bilirubin within normal institutional limits * AST (SGOT)/ALT (SGPT) \< 2.5 X institutional upper limit of normal * eGFR \>= 60mL/min/1.73m2 * Subjects with ECOG performance status of 0 or 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development and validation of tumor detection algorithms in breast cancer patients receiving neoadjuvant therapy | 1 month | Refining of the previously validated tumor detection algorithm in breast cancer patients receiving neoadjuvant therapy will be conducted in the first cohort and the validation of this algorithm will use data from the second cohort. |
| Number of patients with reported adverse events | 14 days | Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity. |
| Reduction in residual tumor | 3 months | Evaluate reduction in residual tumor left after Lumicell assisted lumpectomy compared with SoC removal of main lumpectomy specimen in patients who have received and not received neo-adjuvant therapy |
| Report on patient reported outcomes and patient preference information | 12 months | Collect and summarize patient reported information on outcomes and preference |
Countries
United States
Outcome results
None listed