99mTc/68Ga Labeled Anti-PD-L1 sdAb in Assessment of Programmed Death Ligand-1 Expression in Non-small Cell Lung Cancer
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Semiquantitative Assessment of Lung Lesions in 99mTc-NM-01 SPECT/CT and 68Ga-NM-01 PET Scan
Study Overview
Brief Summary
To evaluate the safety, dosimetry and efficacy of 99mTc/68Ga labeled anti-PD-L1 single domian antibody (sdAb) (Product Code Name: 99mTc-NM-01 and 68Ga-NM-01) 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 99mTc/68Ga labeled anti-PD-L1 sdAb.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Injection of 99mTc-NM-01
All patients with NSCLC who have undergone biopsy of primary tumour lesion will be administered 3-12 MBq/kg of 99mTc-NM-01 in a single injection.
Intervention: Injection of 99mTc-NM-01 (Procedure)
Injection of 68Ga-NM-01
All patients with NSCLC who have undergone biopsy of primary tumour lesion will be administered 0.75- 4 MBq/kg of 68Ga-NM-01 in a single injection.
Intervention: Injection of 68Ga-NM-01 (Procedure)
Outcomes
Primary Outcomes
Semiquantitative Assessment of Lung Lesions in 99mTc-NM-01 SPECT/CT and 68Ga-NM-01 PET Scan
Time Frame: 1 year
Patients in the 99mTc-NM-01 group will be administered 3-12 MBq/kg of 99mTc-NM-01 and patients in the 68Ga-NM-01 group will be administered 0.75-4 MBq/kg of 68Ga-NM-01. 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%.
Visual Assessment of PD-L1 expression in NSCLC using 99mTc-NM-01 SPECT/CT and 68Ga-NM-01 PET/CT Scan
Time Frame: 1 year
Visual analysis will be carried out by 4 experienced nuclear medicine physicians to observe the uptake of 99mTc-NM-01 and 68Ga-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.
Secondary Outcomes
- PD-L1 expression levels(1 year)
- Adverse Drug Reaction Report(7 days)
- New tumor lesion detection(1 year)
Investigators
Zhao Jin Hua, MD
Director Department of Nuclear Medicine, Principal Investigator, Professor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine