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CompletedPhase 1NCT04315467
Official study title

Intraoperative Imaging of Pulmonary Nodules by SGM-101

Study 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.

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Key things to know

Main goalOther

This describes the study’s primary purpose.

What is being studiedSGM-101 and Near infrared camera imaging system

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 16, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Sunil Singhal

Study sponsor

01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Surgery→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

04
Study sites

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.

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