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

JRCT ID: jRCTs051180147

Registered date:20/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 28/06/2017
• Target sample size: 25
• Study type: Interventional
• Intervention(s): All patients undergo FLT-PET/MRI before and 2 and 6 weeks after initiation of PD-1 immune checkpoint inhibitors.

Outcome(s)

• Primary Outcome: Relationship between serial FLT-PET/MRI findings of the tumor and progression free survival and tumor response.

Secondary Outcome

1. Association of serial change of FLT-PET/MRI findings with overall survival.
2. Association of FLT-PET/MRI findings and PD-L1 expression of lung cancer.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Umeda Yukihiro
• Secondary ID(s): UMIN000027460