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Spots Global Cancer Trial Database for Feasibility Study of Intraoperative Detection of Residual Cancer in Breast Cancer Patients

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Trial Identification

Brief Title: Feasibility Study of Intraoperative Detection of Residual Cancer in Breast Cancer Patients

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

Study ID: NCT04440982

Interventions

Study Device Arm

Study Description

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 1.0 mg/kg. 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 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. 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Stanford Hospital and Clinics, Palo Alto, California, United States

Morton Plant Mease Health Care Oncology Research, Clearwater, Florida, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

Duke Cancer Center, Durham, North Carolina, United States

Novant Health Cancer Center, Winston-Salem, North Carolina, United States

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Contact Details

Name: Barbara Smith, MD, PhD

Affiliation: Massachusetts General Hospital

Role: PRINCIPAL_INVESTIGATOR

Name: Jorge Ferrer, PhD

Affiliation: Lumicell, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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