NCT03834272

Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies

Feasibility of the LUM Imaging System for Detection of Peritoneal Surface Malignancies

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Lumicell, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this feasibility study is 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 a dose escalation phase to select the optimal dose.

Detailed description

Subjects will be recruited and screened at a single institution, Massachusetts General Hospital. All subjects will have an established diagnosis of metastases to the peritoneum from primary colonic, appendiceal, or ovarian cancer or mesothelioma and are scheduled for surgical debulking. This study consists of a dose escalation and imaging timepoint evaluation. 18 patients will be enrolled into this study.

Conditions

• Peritoneal Metastases

Interventions

Type	Name	Description
COMBINATION_PRODUCT	LUM Imaging System	Patients will be injected with one of 3 study doses of LUM015 and tissue will be imaged in vivo with the LUM imaging device. Some patients may be imaged with an additional imaging device.

Timeline

• Start date: 2019-03-18
• Primary completion: 2025-08-19
• Completion: 2025-08-19
• First posted: 2019-02-07
• Last updated: 2026-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study