Evaluation of treatment response for immune checkpoint inhibitors in non-small cell lung cancer patients using [18F]F-AraG PET/CT

JRCT ID: jRCTs051220109

Registered date:26/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 26/10/2022
• Target sample size: 60
• Study type: Interventional

Intervention(s)

1) Perform 1st [18F]F-AraG PET/CT scanning within 2 weeks before the initial administration of immune checkpoint inhibitors
2) Perform 2nd [18F]F-AraG PET/CT scanning between 2 weeks and 6 weeks after the initial administration of immune checkpoint inhibitors

Outcome(s)

• Primary Outcome: Estimation of effective period of immune checkpoint inhibitors using [18F]F-AraG PET/CT by calculating delta SUVmax of primary site before and after starting immune checkpont inhibitors in non-small cell lung cancer patients.

Secondary Outcome

# Correlation of SUVmax, SUVmean, and the value of SUVmean multiplied by volume of interest in the 1st [18F]F-AraG PET/CT scanning, and the expression rate of CD8, PD-1, and Treg cells in pathological specimens from the primary site and available lymph nodes.
# Comparison of pretreatment [18F]FDG PET/CT vs [18F]F-AraG PET/CT in terms of correlation of SUVmax, SUVmean, and the value of SUVmean multiplied by volume of interest and the expression rate of CD8, PD-1, and Treg cells in pathological specimens from the primary site and available lymph nodes.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1) Confirmed non-small cell lung cancer by pathology.
2) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2.
3) Patients without history of immune checkpoint inhibitors approved in Japan, but clinically applicable and planned to be prescribed.
4) Patients who performed FDG-PET/CT

Exclude criteria

1) Pregnant, possibly pregnant, or breastfeeding women.
2) Very poor physical condition.
3) Outstandingly difficult in communication.

Related Information

• Primary Sponsor: Nakamoto Yuji
• Secondary Sponsor: Nobashi W Tomomi