99mTc Labeled Anti-PD-L1 sdAb SPECT/CT in Assessment of PD-L1 Expression in NSCLC
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Injection of 99m-Tc-NM-01
Sponsored by
About this trial
This is an interventional diagnostic trial for Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed
- Male or female, aged 18-75 years old
- Previous diagnosis of non-small cell carcinoma, confirmed with pathology tests
- AST, ALT, BUN, Cr not more than double the normal values
- Patients with no current history of hepatitis A, hepatitis B, AIDS, tuberculosis and other infectious diseases
Exclusion Criteria:
- Severe infection
- Unable to provide biopsy sample for testing PD-L1 expression level
- Patients with pacemakers
- Pregnant and lactating women
- Investigators professional decision that the subject should not participate in this clinical study
Sites / Locations
- Shanghai General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Injection of 99m-Tc-NM-01
Arm Description
All patients with NSCLC who have undergone biopsy of primary tumour lesion will be administered 3-12 MBq/kg of 99m-Tc-NM-01 in a single injection.
Outcomes
Primary Outcome Measures
Visual Assessment of PD-L1 expression in NSCLC using 99m-Tc-NM-01 SPECT/CT Scan
Visual analysis will be carried out by 4 experienced nuclear medicine physicians to observe the uptake of 99m-Tc-NM-01 in lung lesions.A 4 point system will be used to interpret the scans for abnormalities. It is categorised as such: score 0, no abnormal increased uptake; score 1, low increased uptake; score 2, moderate increased uptake; score 3, high increased uptake. The lesion will be considered positive for malignancy if the score is 2 or higher.
Semiquantitative Assessment of Lung Lesions in 99m-Tc-NM-01 SPECT/CT Scan
Each patient will be administered 3-12 MBq/kg of 99m-Tc-NM-01 and the semiquantitative analysis of the region of interest (ROI) will be performed in lung lesions. Higher level of PD-L1 expression (Tumor proportion score, TPS), higher ROI in tumor. No expression TPS < 1%; Low expression TPS 1 - 49%; High expression TPS ≥ 50%.
Secondary Outcome Measures
PD-L1 expression levels
Patients biopsy sample will be tested to confirm the levels of PD-L1 expression using Human PD-L1 ELISA Kit.
Adverse Drug Reaction Report
Monitor adverse events within 7 days after the injection and scanning to establish the safety of 99m-Tc-NM-01 in patients.
New tumor lesion detection
SPECT/CT scans using 99m-Tc-NM-01 may detect new tumor areas, which can be further proven by biopsy method in order to rule out any false positive results.
Full Information
NCT ID
NCT02978196
First Posted
November 22, 2016
Last Updated
April 13, 2023
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
NanoMab Technology (UK) Limited
1. Study Identification
Unique Protocol Identification Number
NCT02978196
Brief Title
99mTc Labeled Anti-PD-L1 sdAb SPECT/CT in Assessment of PD-L1 Expression in NSCLC
Official Title
99mTc Labeled Anti-PD-L1 sdAb in SPECT/CT Assessment of Programmed Death Ligand-1 Expression in Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
NanoMab Technology (UK) Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the safety, dosimetry and efficacy of 99m-Tc labeled anti-PD-L1 single domian antibody (sdAb) (Product Code Name: 99mTc-NM-01)SPECT/CT in the diagnostic imaging PD-L1 expression in Non-Small Cell Lung Cancer (NSCLC) and compare it with the existing gold standard "biopsy PD-L1 detection". It is also to establish a new clinical method of non-invasive PD-L1 expression detection in NSCLC using 99m-Tc labeled anti-PD-L1 sdAb.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Injection of 99m-Tc-NM-01
Arm Type
Experimental
Arm Description
All patients with NSCLC who have undergone biopsy of primary tumour lesion will be administered 3-12 MBq/kg of 99m-Tc-NM-01 in a single injection.
Intervention Type
Procedure
Intervention Name(s)
Injection of 99m-Tc-NM-01
Intervention Description
Patient is injected with micro-dose of 99m-Tc-NM-01
Primary Outcome Measure Information:
Title
Visual Assessment of PD-L1 expression in NSCLC using 99m-Tc-NM-01 SPECT/CT Scan
Description
Visual analysis will be carried out by 4 experienced nuclear medicine physicians to observe the uptake of 99m-Tc-NM-01 in lung lesions.A 4 point system will be used to interpret the scans for abnormalities. It is categorised as such: score 0, no abnormal increased uptake; score 1, low increased uptake; score 2, moderate increased uptake; score 3, high increased uptake. The lesion will be considered positive for malignancy if the score is 2 or higher.
Time Frame
1 year
Title
Semiquantitative Assessment of Lung Lesions in 99m-Tc-NM-01 SPECT/CT Scan
Description
Each patient will be administered 3-12 MBq/kg of 99m-Tc-NM-01 and the semiquantitative analysis of the region of interest (ROI) will be performed in lung lesions. Higher level of PD-L1 expression (Tumor proportion score, TPS), higher ROI in tumor. No expression TPS < 1%; Low expression TPS 1 - 49%; High expression TPS ≥ 50%.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
PD-L1 expression levels
Description
Patients biopsy sample will be tested to confirm the levels of PD-L1 expression using Human PD-L1 ELISA Kit.
Time Frame
1 year
Title
Adverse Drug Reaction Report
Description
Monitor adverse events within 7 days after the injection and scanning to establish the safety of 99m-Tc-NM-01 in patients.
Time Frame
7 days
Title
New tumor lesion detection
Description
SPECT/CT scans using 99m-Tc-NM-01 may detect new tumor areas, which can be further proven by biopsy method in order to rule out any false positive results.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed
Male or female, aged 18-75 years old
Previous diagnosis of non-small cell carcinoma, confirmed with pathology tests
AST, ALT, BUN, Cr not more than double the normal values
Patients with no current history of hepatitis A, hepatitis B, AIDS, tuberculosis and other infectious diseases
Exclusion Criteria:
Severe infection
Unable to provide biopsy sample for testing PD-L1 expression level
Patients with pacemakers
Pregnant and lactating women
Investigators professional decision that the subject should not participate in this clinical study
Facility Information:
Facility Name
Shanghai General Hospital
City
Shanghai
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
22658127
Citation
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Results Reference
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PubMed Identifier
20516446
Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
Heskamp S, Hobo W, Molkenboer-Kuenen JD, Olive D, Oyen WJ, Dolstra H, Boerman OC. Noninvasive Imaging of Tumor PD-L1 Expression Using Radiolabeled Anti-PD-L1 Antibodies. Cancer Res. 2015 Jul 15;75(14):2928-36. doi: 10.1158/0008-5472.CAN-14-3477. Epub 2015 May 14.
Results Reference
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PubMed Identifier
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Citation
Josefsson A, Nedrow JR, Park S, Banerjee SR, Rittenbach A, Jammes F, Tsui B, Sgouros G. Imaging, Biodistribution, and Dosimetry of Radionuclide-Labeled PD-L1 Antibody in an Immunocompetent Mouse Model of Breast Cancer. Cancer Res. 2016 Jan 15;76(2):472-9. doi: 10.1158/0008-5472.CAN-15-2141. Epub 2015 Nov 10.
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Results Reference
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99mTc Labeled Anti-PD-L1 sdAb SPECT/CT in Assessment of PD-L1 Expression in NSCLC
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