FLT-PET/MRI imaging for the evaluation of early response to immune checkpoint inhibitors

Not Applicable

• Conditions: on-small cell lung cancer; D002289

• Registration Number: JPRN-jRCTs051180147
• Lead Sponsor: meda Yukihiro

Brief Summary

This prospective study showed that changes in TLP measured by 18F-FLT PET as early as 2 weeks after treatment initiation could have utility as predictors of the response and progression-free survival of NSCLC patients treated with anti-PD-1 antibody therapy.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-20
• Study Completion: 2020-01-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1) Age 20 or over.
2) Patients with pathologically confirmed advanced non-small cell lung cancer (NSCLC), and indication of PD-1 immune checkpoint inhibitors (nivolumab or pembrolizumab).
3) Written informed consent.

Exclusion Criteria

1) Patients with metallic device in their body.
2) Patients with claustrophobia.
3) Pregnant or lactating woman.
4) Other cases attending physician it is determined unsuitable for registration of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relationship between serial FLT-PET/MRI findings of the tumor and progression free survival and tumor response.

Secondary Outcome Measures

Name	Time	Method
1. Association of serial change of FLT-PET/MRI findings with overall survival. <br>2. Association of FLT-PET/MRI findings and PD-L1 expression of lung cancer.