Ignite Creation Date:
2024-05-06 @ 2:50 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04440982
Status:
TERMINATED
Last Update Posted:
2024-03-13
First Post:
2020-06-12
Brief Title:
Feasibility Study of Intraoperative Detection of Residual Cancer in Breast Cancer Patients
Sponsor:
Lumicell Inc
Organization:
Lumicell Inc
Study Overview
Official Title:
Feasibility Study to Evaluate Performance of the LUM Imaging System for Intraoperative Detection of Residual Tumor in Breast Cancer Patients Receiving and Not Receiving Neoadjuvant Therapy
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Required resources unavailable
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 10 mgkg 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 31 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
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 10 mgkg 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 31 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01CA212138-01 | NIH | None | httpsreporternihgovquickSearch1R01CA212138-01 |