Intraoperative Imaging of Pulmonary Nodules by SGM-101

NCT04315467 | Completed Phase 1 FDA Drug FDA Device

• 2 other identifiers: 834577UPCC#: 02519
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 utilizing intraoperative imaging.

Conditions

Lung Cancer; Lung Nodule; Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (1)

SGM-101

EXPERIMENTAL

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.

Drug: SGM-101; Device: Near infrared camera imaging system

Interventions

SGM-101 DRUG

A one-time infusion of SGM-101

Also known as: fluorochrome-labeled anti-carcino-embryonic antigen (CEA) monoclonal antibody

SGM-101

Near infrared camera imaging system DEVICE

Near infrared camera imaging system

SGM-101

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunil Singhal: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Azari F, Meijer RPJ, Kennedy GT, Hanna A, Chang A, Nadeem B, Din A, Pelegrin A, Framery B, Cailler F, Sullivan NT, Kucharczuk J, Martin LW, Vahrmeijer AL, Singhal S. Carcinoembryonic Antigen-Related Cell Adhesion Molecule Type 5 Receptor-Targeted Fluorescent Intraoperative Molecular Imaging Tracer for Lung Cancer: A Nonrandomized Controlled Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2252885. doi: 10.1001/jamanetworkopen.2022.52885.

  PMID: 36705924 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Antibodies, Monoclonal

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Sunil Singhal, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor in Surgical Research

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 19, 2020
• Study Start: July 8, 2020
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: June 16, 2022

Record last verified: 2022-06

Locations

US (1)