Lung Cancer Clinical Trial
Official title:
Intraoperative Molecular Imaging Of Pulmonary Nodules By SGM-101, A Fluorochrome-Labeled Anti-Carcino-Embryonic Antigen (CEA) Monoclonal Antibody
Verified date | June 2022 |
Source | Abramson Cancer Center of the University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | February 10, 2022 |
Est. primary completion date | February 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Sunil Singhal |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity measure of SGM-101 uptake and expression in identifying non-small cell lung cancer | 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). | Up to 10 days post surgery (completion of pathology report) | |
Primary | Specificity measure of SGM-101 uptake and expression in identifying non-small cell lung cancer | 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) | |
Primary | Number of Adverse Events (AEs) and Treatment-emergent Adverse Events (TEAEs) | 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) |
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