99mTc Labeled Anti-PD-L1 sdAb SPECT/CT in Assessment of PD-L1 Expression in NSCLC

Study Overview
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Brief Summary
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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.

Official Title
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99mTc Labeled Anti-PD-L1 sdAb in SPECT/CT Assessment of Programmed Death Ligand-1 Expression in Non-small Cell Lung Cancer

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Procedure: Injection of 99m-Tc-NM-01


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injection of 99m-Tc-NM-01<br>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. | Procedure: Injection of 99m-Tc-NM-01<br>* Patient is injected with micro-dose of 99m-Tc-NM-01<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 
| 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%. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD-L1 expression levels | Patients biopsy sample will be tested to confirm the levels of PD-L1 expression using Human PD-L1 ELISA Kit. | 1 year | 
| 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. | 7 days | 
| 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. | 1 year |