Feasibility Study of Intraoperative Detection of Residual Cancer in Breast Cancer Patients Receiving Neoadjuvant Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04440982|
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : November 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Neoadjuvant Therapy||Combination Product: Study Device Arm||Phase 2|
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. Surgeons will perform main specimen resection per standard of care. Prior to removing any shaves as part of the standard of care, the surgeon will use the Lum System to scan and image all orientations within the cavity. The LUM Imaging System will guide shave removal. Then, 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. 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. The LUM Imaging System will be used in both arms to capture images of each tissue removed, whether LUM-guided or part of the final comprehensive shave removal. Data from both arms of the study will be used to determine the diagnostic performance (sensitivity and specificity) of the LUM Imaging System in patients who have received 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Subjects will be randomized to receive the device intervention. All subjects will receive the study drug.|
|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.|
|Official Title:||Feasibility Study to Evaluate Performance of the LUM Imaging System for Intraoperative Detection of Residual Tumor in Patients With Breast Cancer Receiving Neoadjuvant Therapy|
|Actual Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||August 2025|
|Estimated Study Completion Date :||December 2025|
Experimental: Device Intervention: LUM Imaging System used during surgery
The LUM Imaging Device will be used to look inside the lumpectomy cavity to see if the dye indicates any areas that may contain residual tumor. If the imaging identifies that there may be cancer cells remaining in the lumpectomy cavity, the surgeon will remove an additional piece of tissue. This process will be continued until a negative reading from the device is obtained or a maximum of 2 shaves of additional tissue has been removed. Patients in this arm will receive the study drug, LUM015
Combination Product: Study Device Arm
LUM015 will be administered 2 to 6 hours prior to surgery. The LUM Imaging device will be used to assist in the removal of additional tumor tissue.
Other Name: LUM Imaging System
No Intervention: Standard of Care Arm
The LUM Imaging Device will not be used to guide additional tissue removal. Patients in this arm will receive the study drug, LUM015.
- Sensitivity and specificity of the system will be evaluated by comparing the imaging result with pathology findings of the imaged tissue [ Time Frame: 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 [ Time Frame: 14 days ]Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04440982
|Contact: Jorge Ferrer, PhDfirstname.lastname@example.org|
|Contact: Kate Smith, MPH, CCRPemail@example.com|
|United States, California|
|Stanford University Medical Center||Not yet recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Irene Wapnir, MD|
|Principal Investigator: Irene Wapnir, MD|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Barbara Smith, MD, PhD|
|Principal Investigator: Barbara Smith, MD, PhD|
|United States, North Carolina|
|Duke University Medical Center||Not yet recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Shelley Hwang, MD|
|Principal Investigator: Shelley Hwang, MD|
|United States, Texas|
|MD Anderson Cancer Center||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Contact: Kelly Hunt, MD|
|Principal Investigator: Kelly Hunt, MD|
|Principal Investigator:||Barbara Smith, MD, PhD||Massachusetts General Hospital|
|Study Director:||Jorge Ferrer, PhD||Lumicell, Inc.|