Breast Cancer Clinical Trial
— INSITEOfficial title:
Pivotal Study of the LUM Imaging System for Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patients With Breast Cancer
Verified date | July 2023 |
Source | Lumicell, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multi-center, two-arm randomized, blinded pivotal study to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in identifying residual cancer in the lumpectomy bed of female breast cancer patients undergoing breast surgery in order to assist surgeons in reducing the rates of positive margins. All enrolled subjects will be injected with LUM015 prior to surgery. Surgeons are blinded to whether a participant will be randomized into the device arm until after the standard of care lumpectomy is complete. Participants will then be randomized to receiving the device. Therapeutic (LUM guided) shaves will be removed based on the guidance of the LUM Imaging System. Patients will be followed until their first standard of care post-operative follow-up visit.
Status | Completed |
Enrollment | 406 |
Est. completion date | May 4, 2022 |
Est. primary completion date | December 9, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 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 breast cancer, as per the exclusion criteria listed below. - Subjects must have organ and marrow function within limits as defined below: - Leukocytes > 3,000/microlitre (mcL). - Platelets > 75,000/mcL - total bilirubin within normal institutional limits - Aspartate aminotransferase (AST (SGOT))/alanine transaminase (ALT (SGPT)) < 2.5 X institutional upper limit of normal - Creatinine = 1.5 mg/dL or creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal. - Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: - Subjects who have been diagnosed with bilateral breast cancer and are undergoing bilateral resection procedure - Subjects who are pregnant. Breastfeeding should be discontinued if the mothers is treated with Pegulicianine (LUM015) - Subjects who are sexually active and not willing/able to use 2 medically acceptable forms of contraception (hormonal or barrier method of birth control, abstinence) upon entering the study and for 60 days after injection of LUM015. - Subjects who have taken an investigational drug within 30 days of enrollment. - Subjects who will have administration of methylene blue or any dye for sentinel lymph node mapping on the day of the surgery prior to imaging the lumpectomy cavity with the LUM Imaging Device. - Subjects who have not recovered from adverse events due to other pharmaceutical or diagnostic agents. - Subjects with uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 110 mm Hg; those subjects with known hypertension (HTN) should be stable with controlled HTN while under pharmaceutical therapy. - History of allergic reaction to polyethylene glycol (PEG). - History of allergic reaction to any oral or intravenous contrast agents. - Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, chronic obstructive pulmonary disease (COPD) or asthma requiring hospitalization within the past 12 months, or psychiatric illness/social situations that would limit compliance with study requirements. - HIV-positive individuals on combination antiretroviral therapy are ineligible. - Any subject for whom the investigator feels participation is not in the best interest of the subject. - Subjects undergoing a second lumpectomy procedure because of positive margins in a previous surgery prior to entering this study - Subjects with post-biopsy hematomas greater or equal to 2 cm that are visible on physical exam or detected during pre-operative observations. - Subjects with prior ipsilateral breast cancer surgeries, mastectomies, breast reconstructions or implants.s with prior ipsilateral breast cancer surgeries, mastectomies, breast reconstructions or implants - Subjects with prior ipsilateral reduction mammoplasties (breast reductions) performed less than 2 years prior to enrollment to this study. - Subjects previously treated with systemic therapies to treat the cancer to be removed during this clinical investigation, such as neo-adjuvant chemotherapy or hormonal therapy. - Subjects undergoing breast conserving surgery whose resected specimen (main lump, shaves, or any other resected tissue) will be evaluated with frozen section after the LUM-guided removal of shaves. |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Morton Plant Mease Health Care Oncology Research | Clearwater | Florida |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Duke Cancer Center | Durham | North Carolina |
United States | Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | Baptist MD Anderson Cancer Center | Jacksonville | Florida |
United States | University of South Alabama Mitchell Cancer Institute | Mobile | Alabama |
United States | Stanford Hospital and Clinics | Palo Alto | California |
United States | Comprehensive Breast Care Center/Beaumont Health | Royal Oak | Michigan |
United States | HonorHealth Research Institute | Scottsdale | Arizona |
United States | CHI Franciscan Research Center | Tacoma | Washington |
United States | Moffitt Cancer Center | Tampa | Florida |
United States | Novant Health Salem Surgical Associates | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Lumicell, Inc. | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Patients Who Had Residual Cancer Found in at Least One LUM Imaging System Guided Shave Among All Patients. | Residual cancer was defined as tumor found by pathology in a therapeutic shave after the SOC surgical procedure was completed; that is, tumor that current Standard of Care (SOC) surgery failed to remove. LUM Imaging System was used during the surgery, but the assessment of the outcomes was unknown until the pathology report was available. | Day 1, during surgery | |
Primary | Sensitivity of LUM Imaging System on Cancer in the Lumpectomy Cavity | Sensitivity of LUM Imaging System on cancer was calculated as percentage of tissues with cancer that was removed from lumpectomy cavity due to positive detection by LUM Imaging System. The estimates of the instrument diagnostic sensitivity used Generalized Estimating Equations (GEE) approach. This method was used to analyze correlated data which was modeled with generalized linear model having binomial link function and including correlation cluster and matrix information (here within each subject). LUM Imaging System was used during the surgery, but the assessment of the outcomes was unknown until the pathology report was available. | Day 1, during surgery | |
Primary | Specificity of LUM Imaging System Detection on Cancer in the Lumpectomy Cavity | Specificity of LUM Imaging System Detection on Cancer in the Lumpectomy Cavity was measured as percentage of the negative margins without cancer, that were tested negative by LUM Imaging System. The estimate of the instrument diagnostic specificity used Generalized Estimating Equations (GEE) approach with random effects from intraclass correlation within subjects. | Day 1, during surgery | |
Secondary | Detection and Conversion of Positive Margins. | Detection of positive margins: Percentage of patients with positive margins after standard of care breast-conserving surgery, all had LUM Imaging System signals above the threshold in the cavity as defined by the tumor detection algorithm. Conversion of positive margins: Percentage of patients with positive margins after standard of care breast-conserving surgery resulted in the negative margin after LUM Imaging System was used. The system was used during the surgery, but the assessment of the outcomes was unknown until the pathology report was available. |
Day 1, during surgery | |
Secondary | Removal of Residual Cancer Guided by the LUM Imaging System in Participants With Negative Margins After Standard-of-Care Surgery | Percentage of participants having residual tumor removed within subpopulation of having negative margins after Standard of Care surgery. The system was used during the surgery, but the assessment of the outcomes was unknown until the pathology report was available. | Day 1, during surgery | |
Secondary | Removal of Residual Cancer Guided by the LUM Imaging System in Subjects With Positive Margins After Standard-of-Care Surgery | Percentage of participants having residual tumor removed within subpopulation of having positive margins after Standard of Care surgery. The system was used during the surgery, but the assessment of the outcomes was unknown until the pathology report was available. | Day 1, during surgery | |
Secondary | Volume of Therapeutic Shaves Removed During Lumpectomy. | The median volumes of Lumicell Imaging System - guided shaves (therapeutic shaves) were measured and the median total volume removed during lumpectomy was presented as well. The system was used during the surgery, but the assessment of the outcomes was unknown until the pathology report was available. | Day 1, during surgery | |
Secondary | Contribution of Therapeutic Shaves to Total Volume Removed During Lumpectomy. | Median of the percentages of the volumes of Lumicell Imaging System - guided shaves (therapeutic shaves) out of total volume removed during lumpectomy for each participant were measured. The system was used during the surgery, but the assessment of the outcomes was unknown until the pathology report was available. | Day 1, during surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Recruiting |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |