Intraoperative Imaging of Pulmonary Nodules by SGM-101

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunil Singhal
• Treatments: Antibodies; Antibodies, Monoclonal

Criteria

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.