- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04315467
Intraoperative Imaging of Pulmonary Nodules by SGM-101
Intraoperative Molecular Imaging Of Pulmonary Nodules By SGM-101, A Fluorochrome-Labeled Anti-Carcino-Embryonic Antigen (CEA) Monoclonal Antibody
Study Overview
Status
Conditions
Intervention / Treatment
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 operation and the study. There will be no randomization or control group and only subjects previously scheduled to undergo surgery will be eligible to participate. The investigators anticipate a 24-month period will be necessary to reach the accrual goal of 20 subjects.
After obtaining informed consent, subjects who are confirmed as eligible will receive a one-time dose of 5 to 10 mg of SGM-101, up to 5 days prior to the planned operation. As a prophylactic measure, the Principal Investigator may recommend giving 25 mg of IV Benadryl to the subject prior to the infusion of SGM-101 to ensure the possibility of an allergic reaction is absolutely minimized. The goal of surgery in subjects is to remove the nodule and lymph nodes in concern. During surgery, the investigators will take images with an intra-operative camera system. Imaging will take place prior to surgical resection to record the localization of tumors, and post-resection to document the visualization of any residual tumor.
The duration of surgical procedures to resect thoracic malignancies varies substantially, anywhere from 2-6 hours or more. It is estimated that visualization of the chest and removal of nodules for the purposes of this study will require an additional ten (10) minutes. Due to potential quenching of the fluorophore, visualization time will be limited to 30 minutes.
Cohort 1: The first 10 subjects will be a feasibility trial. The investigators will discover whether lung non-small cell lung cancers fluoresce based on the intraoperative images. The surgeon will look at the images during surgery to determine if the tumor is glowing or not. In the first 10 subjects, if the investigators identify 5 or more subjects with a false positive, then the investigators will review the data prior to proceeding. If the investigators have a high false positive rate, then the investigators will likely not proceed because the clinical value of the fluorescent probe is minimal. Of note, if the first five consecutive subjects have false positives, the investigators will stop the study and analyze the data carefully before proceeding with the study.
Cohort 2: If the first 10 subjects show no significant false positives, then the investigators will continue to examine another 10 subjects.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center of the University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SGM-101
SGM-101 (5-10 mg) will be administered intravenously over 30 minutes followed by a 50 mL flush of isotonic saline to account for the dead volume of the tubing.
SGM-101 will be administered 3 to 5 days (+/-1 day) prior to surgery.
As a prophylactic measure to ensure the possibility of allergic reaction is absolutely minimized, 25 mg of IV Benadryl may be given the subject prior to the infusion of SGM-101 at the discretion of the Principal Investigator.
|
Near infrared camera imaging system
A one-time infusion of SGM-101
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity measure of SGM-101 uptake and expression in identifying non-small cell lung cancer
Time Frame: Up to 10 days post surgery (completion of pathology report)
|
The sensitivity measure will be based on the single lung nodule that is being removed from each subject included in the study.
The sensitivity measure is calculated by dividing the number of True Positives (fluorescent nodule, pathology is cancer) by True Positives plus False Negatives (not fluorescent nodule, pathology is cancer).
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Up to 10 days post surgery (completion of pathology report)
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Specificity measure of SGM-101 uptake and expression in identifying non-small cell lung cancer
Time Frame: Up to 10 days post surgery (completion of pathology report)
|
The specificity measure will be based on the single lung nodule that is being removed from each subject included in the study.
The specificity measure is calculated by dividing the number of True Negatives (not fluorescent nodule, pathology is no cancer) by True Negatives plus False Positives (fluorescent nodule, pathology is no cancer).
|
Up to 10 days post surgery (completion of pathology report)
|
Number of Adverse Events (AEs) and Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to 4 weeks post surgery (completion of post-operative follow-up visit)
|
The safety of the study will be determined via incidence rates of all AEs and TEAEs from the time of SGM-101 administration through post-operative follow-up visit.
|
Up to 4 weeks post surgery (completion of post-operative follow-up visit)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sunil Singhal, MD, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 834577
- UPCC#: 02519 (Other Identifier: UPENN Abramson Cancer Center)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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