Lung CancerPhase 1NCT04315467
Intraoperative Imaging of Pulmonary Nodules by SGM-101
A Phase 1 study testing SGM-101 and Near infrared camera imaging system in people with Lung Cancer and Lung Nodule, run by Sunil Singhal at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lung Nodule, Non Small Cell Lung Cancer
- What is being tested?
- SGM-101 and Near infrared camera imaging system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2020to 10 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Intraoperative Molecular Imaging Of Pulmonary Nodules By SGM-101, A Fluorochrome-Labeled Anti-Carcino-Embryonic Antigen (CEA) Monoclonal Antibody
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.
Read the 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.
- Conditions
- Lung Cancer, Lung Nodule, Non Small Cell Lung Cancer
- Being tested
- SGM-101, Near infrared camera imaging system
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGM-101Drug
Also called fluorochrome-labeled anti-carcino-embryonic antigen (CEA) monoclonal antibody
A one-time infusion of SGM-101
Near infrared camera imaging systemDevice
Near infrared camera imaging system
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: SGM-101; Device: Near infrared camera imaging system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: Up to 4 weeks post surgery (completion of post-operative follow-up visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start8 Jul 2020
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunil Singhal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sunil Singhal, Abramson Cancer Center at Penn Medicine
- Investigators
- Sunil Singhal, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315467
- Sponsor's protocol ID
- 834577
- Other IDs
- UPCC#: 02519
- Status last verified
- Jun 2022
- First submitted
- 13 Mar 2020
- Last updated
- 16 Jun 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
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.
PubMed 36705924
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Molecular Imaging Of Pulmonary Nodules By SGM-101, A Fluorochrome-Labeled Anti-Carcino-Embryonic Antigen (CEA) Monoclonal Antibody
- ClinicalTrials.gov ID
- NCT04315467
- Acronym / sponsor ID
- 834577
- Conditions
- Lung Cancer, Lung Nodule, Non Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sunil SinghalUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGM-101 | Experimental | Drug: SGM-101, Device: Near infrared camera imaging systemSGM-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- At-risk subject populations:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGM-101Also: fluorochrome-labeled anti-carcino-embryonic antigen (CEA) monoclonal antibodyA one-time infusion of SGM-101 | Drug | SGM-101 |
| Near infrared camera imaging systemNear infrared camera imaging system | Device | SGM-101 |
Primary outcome
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).
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Derived from this study: PubMed 36705924Azari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunil Singhal, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SGM-101 and Near infrared camera imaging system in people with Lung Cancer and Lung Nodule, run by Sunil Singhal at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04315467, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.