Clinical trial · Interventional
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
NCT04315467CI-TRIAL-00059158completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Nodule | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Near infrared camera imaging system | Device | — | UNRESOLVED |
| SGM-101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SGM-101
- description
- 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.
- interventionNames
- Drug: SGM-101
- Device: Near infrared camera imaging system
Primary outcomes (3)
- measure
- Sensitivity measure of SGM-101 uptake and expression in identifying non-small cell lung cancer
- timeFrame
- Up to 10 days post surgery (completion of pathology report)
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDAzari 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