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

April 13, 2023 updated by: Zhao Jin Hua, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Shanghai General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Injection of 99m-Tc-NM-01
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
Patient is injected with micro-dose of 99m-Tc-NM-01

What is the study measuring?

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
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 7 days
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
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

NanoMab Technology (UK) Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2018

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

November 22, 2016

First Submitted That Met QC Criteria

November 28, 2016

First Posted (Estimate)

November 30, 2016

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 13, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016KY220

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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