Feasibility Study of Intraoperative Imaging in Breast Cancer

NCT02438358 | Completed Phase 1 Results FDA Drug FDA Device

• 2 other identifiers: LUM-015/2.6-0011R21CA173762
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

For most breast cancer patients, surgery is the primary treatment. When patients undergo a lumpectomy, it is difficult for the surgeon to determine the extent of the tumor which results in incomplete tumor removal as determined by a positive margin assessment several days after the initial surgery is completed. Most patients with positive margins will undergo a second or even a third surgery to complete the tumor removal. The investigators hypothesize that the LUM Imaging System can reduce the rates of positive margins and, thus, the rates of second surgeries by identifying microscopic residual cancer in the tumor bed. This is a non-randomized, open label study to evaluate the safety and efficacy of an intraoperative imaging system, the LUM Imaging System (LUM015 in conjunction with LUM 2.6 Imaging Device), in identifying residual cancer in the tumor bed of female breast cancer subjects. The study is composed of a Feasibility Trial divided into two phases: Phase A (15 total subjects) and Phase B (up to 50 total subjects). During Phase A, 15 subjects will be evaluated to collect additional patient safety data, select the dose of LUM015 for Phase B and evaluate the device function. During Phase B, subjects will be injected with LUM015 at the dose determined during Phase A to preliminarily assess the performance of the detection algorithm against pathology margin assessment. In Phase B, the surgeon will perform standard of care surgery and then use the LUM Imaging System to guide the removal of additional cavity shavings as indicated by the LUM Imaging System.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• (Phase A Only) Selection of Dose of LUM015 to be Used in Future Breast Trials

  tumor-to-normal tissue signal ratio as a function of dose of LUM015

  1 day

• (Phase B Only)Sensitivity and Specificity of the Lumicell Imaging System for Detecting Cancer

  Data from the participants in Phase A was used to develop an initial tumor detection algorithm that was then tested in Phase B. Thus, this endpoint is only applicable to the participants enrolled in the Phase B portion of the study. This endpoint measures the ability of the system to detect cancer as measured by sensitivity and specificity as defined below: Sensitivity = \[number of true positives/(number of true positives + number of false negatives)\] x 100% Specificity = \[number of true negatives/(number of true negatives + number of false positives)\] x 100% True positives = positive signal from imaging system and cancer found in tissue by pathology False positives = positive signal from imaging system and no cancer found in tissue by pathology True negatives = negative signal from imaging system and no cancer found in tissue by pathology False negatives = negative signal from imaging system and cancer found in tissue by pathology

  1 day

Secondary Outcomes (1)

• Number of Patients With Adverse Events as a Measure of Safety of the LUM Imaging System in Breast Cancer Subjects.

  Patients were evaluated for adverse events from time of injection until standard post-surgery follow-up visit. (Median 31 days after lumpectomy).

Study Arms (1)

LUM Imaging System

EXPERIMENTAL

No dose or a single dose of LUM015 (0.5 mg/kg or 1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. The dose administered in Phase B will be determined based on results of Phase A. All subjects will have intraoperative imaging using the LUM 2.6 Imaging Device.

Drug: LUM015; Device: LUM 2.6 Imaging Device

Interventions

LUM015 DRUG

LUM Imaging System

LUM 2.6 Imaging Device DEVICE

LUM Imaging System

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed primary breast cancer.
• Female, age of 18 years or older.
• Scheduled for a lumpectomy of a breast tumor.
• Able and willing to follow study procedures and instructions.
• Subjects must have received and signed an informed consent form.

You may not qualify if:

• Subjects must have normal organ and marrow function as defined below:
• Leukocytes \> 3,000/mcL
• Absolute neutrophil count \> 1,500/mcL
• Platelets \> 100,000/mcL
• total bilirubin within normal institutional limits
• AST (SGOT)/ALT (SGPT) \< 2.5 X institutional upper limit of normal
• Creatinine within normal institutional limits or creatinine clearance \> 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
• Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) starting the day entering the study, and for 60 days after injection of the imaging agent.
• Subjects with ECOG performance status of 0 or 1.
• Subjects with a known current condition of substance addiction.
• Subjects who have taken an investigational drug within 30 days of enrollment.
• Subjects with prolonged QT interval.
• Subjects who will have administration of methylene blue or any blue dye used for sentinel node mapping procedures.
• Subjects who have not recovered from adverse events due to pharmaceutical or diagnostic agents administered more than 4 weeks earlier.
• Subjects with uncontrolled hypertension defined as persistent systolic blood pressure \> 150 mm Hg, or diastolic blood pressure \> 95 mm Hg; those subjects with known HTN should be stable within these ranges while under pharmaceutical therapy

Sponsors & Collaborators

• Lumicell, Inc.: lead
• National Cancer Institute (NCI): collaborator
• Massachusetts General Hospital: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

False positive readings may be associated with the LUM015 fluorescent signal extending beyond the tumor border, technical factors related to specimen processing and tissue sampling, and possible poor contact between the optical head and lumpectomy cavity wall, which may have reduced detection of fluorescent signal. This issues will be addressed in future clinical trials.

Results Point of Contact

• Title: Jorge Ferrer, Ph.D.
• Organization: Lumicell

jmferrer@lumicell.com

617-571-0592

Study Officials

• Barbara L Smith, M.D., Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: May 8, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: January 5, 2023
• Results First Posted: January 5, 2023

Record last verified: 2022-12

Locations

US (1)