SGM-101 in Locally Advanced and Recurrent Rectal Cancer
NCT04642924 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 203
Last updated 2020-11-24
Summary
Near-infrared fluorescence-guided oncologic surgery (EGOS) with the use of a tumor specific tracer (SGM-101) developed by Surgimab can provide valuable intra-operative information about tumor location and extensiveness, which can be difficult to detect with conventional visual and tactile feedback. Hence, this information could aid in intra-operative decision making and therewith foster complete resection margins and less extensive surgery. Subsequently, this may drastically improve patient care by improving oncologic outcome.
Conditions
- Rectal Cancer
- Recurrent Rectal Cancer
Interventions
- DRUG
-
SGM-101
Fluorescence-guided surgery
Sponsors & Collaborators
- collaborator OTHER
-
Amsterdam UMC, location VUmc
collaborator OTHER -
Catharina Ziekenhuis Eindhoven
collaborator OTHER -
Medical Center Haaglanden
collaborator OTHER -
Surgimab
collaborator INDUSTRY -
Quest Medical Imaging
collaborator INDUSTRY -
Centre for Human Drug Research, Netherlands
collaborator OTHER -
Leiden University Medical Center
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-22
- Primary Completion
- 2021-10-31
- Completion
- 2023-10-31
Countries
- Netherlands
Study Locations
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