99mTc/68Ga Labeled Anti-PD-L1 sdAb in Assessment of PD-L1 Expression in NSCLC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-15

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Injection of 99mTc-NM-01

Intervention Type PROCEDURE

Patient is injected with micro-dose of 99mTc-NM-01

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.

Group Type EXPERIMENTAL

Injection of 68Ga-NM-01

Intervention Type PROCEDURE

Patient is injected with micro-dose of 68Ga-NM-01

Interventions

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Injection of 99mTc-NM-01

Patient is injected with micro-dose of 99mTc-NM-01

Intervention Type PROCEDURE

Injection of 68Ga-NM-01

Patient is injected with micro-dose of 68Ga-NM-01

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No