A monitoring study for predicting the efficacy of anti-PD-1/PD-L1 inhibitors using FDG-PET/CT and liquid biopsy

A monitoring study for predicting the efficacy of anti-PD-1/PD-L1 inhibitors using FDG-PET/CT and liquid biopsy - A monitoring study for predicting the efficacy of anti-PD-1/PD-L1 inhibitors using FDG-PET/CT and liquid biopsy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000057052

Enrollment

Registered

2025-02-20

Start date

2021-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fifty patients aged 20 years or older with unresectable non-small cell lung cancer scheduled to receive anti-PD-1/PD-L1 inhibitors.

Interventions

After obtaining informed consent, FDG-PET/CT will be performed at three time points: 1: Before treatment, 2: One month after treatment initiation, 3: Four months after treatment initiation. Bloo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Non-small cell lung cancer cases in which FDG-PET/CT has been performed before treatment and the tumor proportion score (TPS) has been determined by PD-L1 immunohistochemical staining.

Exclusion criteria

Exclusion criteria: In cases where consent from the patient or their legal representative is not obtained.

Design outcomes

Primary

Measure	Time frame
FDG-PET/CT: Tumor SUVmax Blood: Exosome-derived PD-L1 protein	—

Secondary

Measure	Time frame
FDG-PET/CT; Metabolic Tumor Volume (MTV), Total Lesion Glycolysis (TLG; SUV mean x MTV), and SUVmax in lymph nodes and metastatic lesions. Blood; Exosome-derived GLUT1/4, number of blood-derived exosomes	—

Countries

Japan

Contacts

Public ContactYohei Kawaguchi

Tokyo Medical University Department of Thoracic and Thyroid Surgery

ykawaguchi219@gmail.com03-3342-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026