drugset / Trial / NCT03834272
Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies
Non-randomizedSequentialOpen-labelDevice feasibility
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.
Timeline
- Start
- 2019-03-18
- Primary completion
- 2025-08-19
- Completion
- 2025-08-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEGULICIANINE ACETATE | Diagnostic / imaging agent | 1 mg/kg | — |
| Subject | PEGULICIANINE ACETATE | Diagnostic / imaging agent | 1.5 mg/kg | — |
| Subject | PEGULICIANINE ACETATE | Diagnostic / imaging agent | 2 mg/kg | — |