Intraoperative Imaging of Pulmonary Nodules by SGM-101
NCT04315467 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2022-06-16
Summary
The primary objectives of this study are to assess the sensitivity and specificity of SGM-101 in detecting non-small cell lung carcinomas during surgery when excited by an near-infrared light source utilizing intraoperative imaging.
Conditions
- Lung Cancer
- Lung Nodule
- Non Small Cell Lung Cancer
Interventions
- DRUG
-
SGM-101
A one-time infusion of SGM-101
- DEVICE
-
Near infrared camera imaging system
Near infrared camera imaging system
Sponsors & Collaborators
-
Sunil Singhal
lead OTHER
Principal Investigators
-
Sunil Singhal, MD · University of Pennsylvania
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-08
- Primary Completion
- 2022-02-10
- Completion
- 2022-02-10
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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