Intraoperative Imaging of Pulmonary Nodules by SGM-101
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.
Checked against the public recordLast updated Jun 16, 2022 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Other
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Sunil Singhal
- Interventions being studied
- Drug: SGM-101; Device: Near infrared camera imaging system
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Adult subjects over 18 years of age * Subjects presenting with a lung, pleural nodule or mass presumed to be resectable on pre-operative assessment * Good operative candidate * Subject is capable of giving informed consent and participating in the process of consent. Exclusion Criteria: * At-risk subject populations: 1. Homeless subjects 2. Subjects with drug or alcohol dependence 3. Children and neonates 4. Subjects unable to participate in the consent process. * Female patients should not be pregnant or lactating. Women of child-bearing potential will be included provided that they have a negative pregnancy test or provide documentation of sterilization, menopausal or post-menopausal status, prior to infusion. * Patients who have received SGM-101 in the past. * Patients who have received any investigational drug four weeks of the injection.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 16, 2022. Always confirm current availability with the study team.