Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Neoplasm, Residual

Breast Diseases

Skin Diseases

Neoplastic Processes

Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects undergo lumpectomy as standard of care and will have the study intervention, guidance by intraoperative imaging using the LUM Imaging Device

Drug: LUM015 Device: LUM 2.6 Imaging Device

LUM Imaging System

Barbara Smith, M.D., Ph.D.

This is a non-randomized, open-label, multi-site study to collect safety and efficacy data on an intraoperative imaging system, the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM imaging device), in identifying residual cancer in the tumor bed of female breast cancer patients. During the study, study physicians and clinical staff will complete hands-on training in anticipation of the upcoming pivotal study. Site-specific or user-specific issues related to the use of the device will be identified and addressed. Additionally, the data collected in the study will be used to continue training the tumor detection algorithm of the device.

In this study, patients will be injected with LUM015 prior to surgery. The study physicians will perform lumpectomy procedures according to his or her institution's standard of care practice. After the main specimen removal is completed, the study physician will use the LUM Imaging Device to image the tumor bed. Therapeutic shaves will be removed based on the recommendation of the LUM Imaging System. Patients will be followed until their first standard of care post-operative follow-up visit.

For breast cancer lumpectomies, the presence of residual cancer cells left in the tumor bed after initial resection in inferred by post-operative margin assessment of the resected tissue by a pathologist.

Phase C enrollment will include approximately 5 patients per surgeon, with 2-3 surgeons per site and up to 20 sites. Subjects undergoing a lumpectomy procedure to treat primary breast cancer will be injected with a single dose of LUM015 4 ± 2 hours prior to surgery at a dose of 1.0 mg/kg. The sequence of events during the surgical procedure will vary based on the standard of care used by the surgeon. Patients will receive at a minimum the standard of care practices for each site. Lumicell-guided shaved cavity margins will be removed after the surgeon has attempted to remove the main specimen with grossly negative margins.

Study treatment ends when the surgery is completed. All patients will continue their enrollment in the study until their first follow-up visit and they will continue to be followed until the medical team determines no further surgical intervention is required. Patients with adverse events that are determined to be possibly related to the LUM Imaging System will be followed until resolution or stabilization of the adverse event.

Intraoperative Detection of Residual Cancer in Breast Cancer

Feasibility Study Phase C: Expansion Into Multiple Institutions for Training in the Use of the LUM Imaging System for Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Subjects With Breast Cancer

Surgeons were trained on using the LUM Imaging System in preparation for participating in future clinical trials with the LUM Imaging System. Workflows were established at each institution to support the use of the LUM Imaging System and protocol adherence during lumpectomy procedures. Surgeons were not participants in the trial. Surgeons were the Investigators in the trial.

Data were collected from mITT population, which included all the patients imaged with the LUM Imaging System.

This metric measured the residual cancer that current Standard of Care (SOC) lumpectomy failed to remove.

It was defined as among all the patients, the percentage of subjects who had residual cancer found in at least one LUM-guided shave (therapeutic shave or "T-shave") after the current initial SOC lumpectomy procedure was completed.

Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.

Collect data to verify the detection algorithm reported in previous studies by SOC margin status

Tumor removal rate was measured as the percentage of the subjects who had residual tumor removed guided by Lumicell Imaging System after standard of care (SOC) procedure within subjects who had positive margins after SOC.

Tumor removal rate was measured as the percentage of the subjects who had residual tumor removed guided by Lumicell Imaging System after standard of care (SOC) procedure within subjects who had negative margins after SOC.

Sensitivity and specificity were measured at the tissue level for the Lumicell imaging signal for the sensitivity and specificity on the residual tumor in the cavity of corresponding orientations after standard of care (SOC) of Lumpectomy. Generalized Estimating Equation (GEE) has been applied using generalized linear model having binomial link function and compound symmetry working correlation structure within each subject.

Conversion was measured as the ratio of the subjects having all the positive margins after BCS SOC converted to negatives after Lumicell Imaging guided procedure.

Detection was measured as the ratio of the subjects having all or at least one positive margin after BCS SOC detected by Lumicell Imaging System.

BCS: Breast-conserving surgery; SOC: Standard of Care

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 contribution of the volumes of Lumicell Imaging System - guided shaves (therapeutic shaves) were measured as percentage of the sum of the volumes of the therapeutic shaves out of the total volume removed during lumpectomy.

National Cancer Institute (NCI)

Lumicell, Inc.

Serious adverse events should be reported within 24 hours of learning of the occurrence. Non-serious adverse events and non-serious adverse device effects will be reported to Lumicell on the adverse events Case Report Forms during the study.

Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects undergo lumpectomy as standard of care and will have the study intervention, guidance by intraoperative imaging using the LUM Imaging Device

LUM Imaging System: LUM015 will be administered 2 to 6 hours prior to surgery. All subjects will have intraoperative imaging using the LUM imaging device.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

One patient did not have the height recorded in the system.

Body Mass Index

Post-menopausal

Pre/Peri-menopausal

Menopausal Status

Mammographic breast density

Palpability

Protocol deviations may have impacted the reported performance. In some patients no LUM shaves were removed either because of protocol deviation or because the protocol limited the number of additional shaves that could be excised at any single margin. These deviations may have precluded full pathologic correlation and evaluation of clinical utility for many of the LUM images and may have prevented conversion of positive margins to negative margins.

Jorge Ferrer, PhD

modified intent to treat population (mITT) includes subjects injected with LUM015 and LUM Imaging was performed

Collect Data to Refine and Verify the Tumor Detection Algorithm.

Chromaturia Adverse Events

Non Chromaturia Adverse Events

Subjects injected with LUM015 at a dose of 1mg/kg.

Number of Patients With Reported Adverse Events

Percentage of subjects with positive SOC margins having tumor in at least one therapeutic shave.

Percentage of subjects with negative SOC margins having tumor in at least one therapeutic shave.

Tumor Removal Rate in the Whole mITT Population by SOC Margin Status

Tumor Removal Rate Within Subjects Having Positive Standard of Care Margins

Tumor Removal Rate Within Subjects Having All Negative SOC Margins

Sensitivity (GEE)

Specificity (GEE)

Sensitivity and Specificity of the LUM Imaging System in Predicting Residual Cancer in the Cavity

Percentage of Subjects Having SOC Positive Margins All Converted to Negative

Percentage of Subjects Having SOC Positive Margins All Detected by Lumicell Device

Percentage of Subjects Having At Least One SOC Positive Margin Detected by Lumicell Device

Detection and Conversion of Positive Margins in Subjects After BCS SOC

Lumpectomy volume (cm3)

SOC shave volume (cm3)

SOC total volume (cm3)

Therapeutic shave volume (cm3)

Total volume (cm3)

Volume of Therapeutic Shaves Removed During Lumpectomy.

Surgeons were trained on using the LUM Imaging System in preparation for participating in future clinical trials with the LUM Imaging System. Workflows were established at each institution to support the use of the LUM Imaging System and protocol adherence during lumpectomy procedures. Surgeons were not participants in the trial.

Number of Surgeons Trained on Using the LUM Imaging System

Thirty-eight surgeons at 16 clinical sites were trained on the use of the LUM Imaging System.

Number of Surgeons Trained on the Use of the LUM Imaging System

Contribution of Therapeutic Shaves to Total Volume Removed During Lumpectomy.

Overall Study

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection at the beginning of the surgery. All subjects will have intraoperative imaging using the LUM Imaging Device

LUM015 will be administered at the beginning of surgery. All subjects will have intraoperative imaging using the LUM imaging device.

Cristina Ferrone, MD

This single-site, non-randomized, open-label study to assess the initial safety and efficacy of the LUM Imaging System for detection of primary pancreatic cancer and peritoneal invasion from primary pancreatic cancer during surgery. In this feasibility study, the tumor detection algorithm will be developed for this indication.

This study is being conducted to see if LUM015 can be safely given to human patients before surgery at a dose that allows the removed tumor tissue to be identified when imaged by the LUM imaging device.

Up to 30 subjects will be enrolled in this study. Subjects will be administered with LUM015 at a dose of 1.0 mg/kg. Due to the expected duration of these surgeries (up to 14 hours), all subjects will require LUM015 administration intraoperatively.

The sequence of events during the surgical procedure will vary based on the standard of care used by the surgeon. Study treatment ends when the surgery is completed. All patients will continue their enrollment in the study until their first follow-up visit and they will continue to be followed until the medical team determines no further surgical intervention is required. Patients with adverse events that are determined to be possibly related to the LUM Imaging System will be followed until resolution or stabilization of the adverse event.

Feasibility Study of LUM Imaging System for Pancreatic Cancer

Feasibility of the LUM Imaging System for Detection of Primary Pancreatic Cancer and Peritoneal Invasion From Primary Pancreatic Cancer During Surgery

Findings from imaging results with the LUM System will be correlated with pathology assessment of the resected tissue.

Glioma

Glioblastoma

Neoplasm Metastasis

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

No LUM015 injection will be given to three (3) patients, in each indication, to measure baseline tissue fluorescence. Imaging with the LUM imaging device will be performed in vivo and ex vivo on surgical tissue.

3 patients, in each indication, will be administered a single dose of LUM015 at 1.0 mg/kg.Imaging with the LUM imaging device will be performed in vivo and ex vivo on surgical tissue.

3 patients, in each indication, will be administered a single dose of LUM015 at 2.0 mg/kg. Imaging with the LUM imaging device will be performed in vivo and ex vivo on surgical tissue.

After an interim analysis, the dosing for the 3 patients, in each indication, will be administered a single dose of LUM015 of no greater than 3.0 mg/kg. Imaging with the LUM imaging device will be performed in vivo and ex vivo on surgical tissue.

Patients will be injected with one of 3 study doses of LUM015, or have no LUM015 intervention, and tissue will be imaged in vivo and ex vivo with the LUM imaging device.

E. Antonio Chiocca, MD, PhD

The overall objective of this study is to assess the safety and efficacy of the LUM Imaging System in imaging primary and metastatic cancer in the brain. This includes selecting a dose to determine the initial efficacy of LUM015 for the molecular imaging of low-grade gliomas, glioblastomas and cancer masses that have metastasized to the brain.

The primary objective of this feasibility study is to identify an effective dose of LUM015 for imaging low grade gliomas, glioblastomas and cancer metastases to the brain. The optimal dose will be used for future studies. Both normal brain tissue and tumor tissue will be imaged and analyzed using the LUM Imaging device. The LUM Imaging System is a combination product consisting of the LUM Imaging Device and the imaging agent LUM015.

Subjects with a possible diagnosis of low grade glioma, glioblastoma and metastases to the brain, and scheduled for surgical resection, will be screened, recruited. On day of scheduled surgery, the subject will be administered with LUM015 4 ± 2 hours prior to using LUM Imaging System during surgery. LUM015 will be administered via peripheral intravenous (IV) injection as a single dose between 1.0 - 3.0 mg/kg.

Before the tumor mass is resected, the LUM Imaging Device will be used to scan images of distinct areas of grossly normal appearing brain tissue and, separately, images of distinct areas of grossly appearing tumor. Following tumor mass resection, the tumor bed is scanned to record in vivo images. The resected tissue will also be imaged ex vivo.

All subjects will continue to be monitored until hospital discharge and followed through their first standard of care post-surgical visit. Subjects with adverse events that are determined to be possibly related to the investigational product will continue to be followed until resolution or stabilization of the adverse event.

Feasibility of the LUM Imaging System for Detection of Cancer to the Brain

Feasibility of the LUM Imaging System for In Vivo and Ex Vivo Detection of Cancer in Subjects With Low Grade Gliomas, Glioblastomas, and Cancer Metastases to the Brain

Correlate the fluorescence levels in normal and tumor tissue from specimen imaging to the dose of LUM015 injected, or if not injected. Determine initial efficacy of LUM015 in labeling primary and metastatic cancer in the Brain by molecular imaging compared with imaging results in pathology.

Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intraoperative Detection of Residual Cancer in Breast Cancer	NCT03321929	Breast Cancer	LUM Imaging Sys...	18 Years -	Lumicell, Inc.
Feasibility Study of LUM Imaging System for Pancreatic Cancer	NCT04276909	Pancreatic Canc...	LUM Imaging Sys...	18 Years -	Lumicell, Inc.
Intraoperative Detection of Residual Cancer in Breast Cancer	NCT03321929	Breast Cancer	LUM Imaging Sys...	18 Years -	Lumicell, Inc.
Feasibility of the LUM Imaging System for Detection of Cancer to the Brain	NCT03717142	Low Grade Gliom... Glioblastoma Metastasis to B...	LUM Imaging Sys...	18 Years -	Lumicell, Inc.
Feasibility of the LUM Imaging System for Detection of Cancer to the Brain	NCT03717142	Low Grade Gliom... Glioblastoma Metastasis to B...	LUM Imaging Sys...	18 Years -	Lumicell, Inc.

Spots Global Cancer Trial Database for lum imaging system