Status:
COMPLETED
Intraoperative Imaging of Pulmonary Nodules by SGM-101
Lead Sponsor:
Sunil Singhal
Conditions:
Lung Cancer
Lung Nodule
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 u...
Detailed Description
Potential subjects will be seen in a General Thoracic Surgery clinic. If potential subjects have a lung nodule that is suspicious for non-small cell lung cancer, they will be a candidate for the opera...
Eligibility Criteria
Inclusion
- 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
- At-risk subject populations:
- Homeless subjects
- Subjects with drug or alcohol dependence
- Children and neonates
- 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.
Key Trial Info
Start Date :
July 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04315467
Start Date
July 8 2020
End Date
February 10 2022
Last Update
June 16 2022
Active Locations (1)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104