Clinical Trials Using Cathepsin-Activatable Cy5 Fluorescent Imaging Probe LUM015

Clinical trials are research studies that involve people. The clinical trials on this list are studying Cathepsin-Activatable Cy5 Fluorescent Imaging Probe LUM015. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-4 of 4
  • Pivotal Study of Intraoperative Detection of Residual Cancer in Breast Cancer Patients

    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 (Lumicell 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.
    Location: 2 locations

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

    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.
    Location: 2 locations

  • Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies

    This single-site, feasibility study to assess the initial safety and efficacy of the LUM Imaging System for in vivo imaging of metastases to the peritoneum from primary gastrointestinal cancer, ovarian cancer and mesothelioma. This feasibility study consists of two parts: (a) a dose escalation phase to select the optimal dose followed by (b) enrollment of additional patients to develop the tumor detection algorithm.
    Location: Massachusetts General Hospital Cancer Center, Boston, Massachusetts

  • Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers

    The overall goal of this feasibility study is to assess the initial safety and efficacy of LUM015 in ex vivo far-red imaging of colorectal, pancreatic, and esophageal cancers (adenocarcinoma) using the LUM 2.6 Imaging Device.
    Location: Massachusetts General Hospital Cancer Center, Boston, Massachusetts