UMIN-CTR Clinical Trial

Basic information
Public title	FLT-PET/MRI imaging for the evaluation of early response to immune checkpoint inhibitors
Acronym	FLT-PET/MRI imaging for the evaluation of early response to immune checkpoint inhibitors
Scientific Title	FLT-PET/MRI imaging for the evaluation of early response to immune checkpoint inhibitors
Scientific Title:Acronym	FLT-PET/MRI imaging for the evaluation of early response to immune checkpoint inhibitors
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Programmed death 1 (PD-1) immune checkpoint inhibitor antibodies were active and durable in some patients with advanced non-small cell lung cancer. However, it is difficult to evaluate early response with conventional imaging (i.e. computed tomography). The aim of this study is to clarify whether serial change of FLT-PET/MRI findings can predict long term tumor response of PD-1 immune checkpoint inhibitor antibody.
Basic objectives2	Others
Basic objectives -Others	To evaluate diagnostic relevancy of FLT-PET/MRI imaging.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Relationship between serial FLT-PET/MRI findings of the tumor and progression free survival and tumor response.
Key secondary outcomes	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.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	All patients undergo FLT-PET/MRI before and 2 and 6 weeks after initiation of PD-1 immune checkpoint inhibitors.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Pathologically confirmed advanced non-small cell lung cancer (NSCLC) 2) Indication of PD-1 immune checkpoint inhibitors (Nivolumab or Pembrolizumab) 3) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 4) Patient with evaluable lesion based on RECIST 5) Written informed consent
Key exclusion criteria	1) Pregnant woman 2) Patients with metalic device in their body 3) Patients with claustrophobia 4) Patients with obvious interstitial pneumonia or pulmonary fibrosis in the chest X-ray. 5) Patients with collagen vascular disease or autoimmune diseases 6) Other cases attending physician it is determined unsuitable for registration of the study
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Yukihiro Middle name Last name Umeda
Organization	University of Fukui
Division name	Third department of internal medicine
Zip code	9101193
Address	23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL	0776-61-3111
Email	umeda@u-fukui.ac.jp

Public contact
Name of contact person	1st name Yukihiro Middle name Last name Umeda
Organization	University of Fukui
Division name	Third department of internal medicine
Zip code	9101193
Address	23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL	0776-61-3111
Homepage URL
Email	umeda@u-fukui.ac.jp

Sponsor
Institute	Third department of internal medicine, Universtiy of Fukui
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Research Ethics Committee of University of Fukui
Address	23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
Tel	0776-61-3111
Email	chiken@ml.cii.u-fukui.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 25 Day

Related information
URL releasing protocol	https://jitc.bmj.com/content/9/7/e003079.long
Publication of results	Published

Result
URL related to results and publications	https://jitc.bmj.com/content/9/7/e003079.long
Number of participants that the trial has enrolled	26
Results	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.
Results date posted	2022 Year 01 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The median age was 70.4 years (range 54 to 82). Histology of the patients was as follows, 11 (44%) with squamous cell carcinoma,9 (36%) with adenocarcinoma, 3 (12%) with NSCLC not otherwise specified, 1 (4%) with large cell carcinoma, and 1 (4%) with pleomorphic carcinoma.
Participant flow	Consecutive 26 patients with advanced NSCLC were prospectively enrolled in this study. Of these, 1 patient did not undergo 2-week 18F-FLT PET/MRI because of discontinuance of pembrolizumab treatment due to drug induced pneumonia, and 3 did not undergo 6-week 18F-FLT PET/MRI because of early disease progression. Therefore, 25 patients were analyzed baseline and 2-week 18F-FLT PET, and 22 patients were analyzed baseline and 6-week 18F-FLT PET.
Adverse events	Any adverse events by 18F-FLT PET/MRI were not observed.
Outcome measures	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.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 24 Day
Date of IRB	2017 Year 05 Month 22 Day
Anticipated trial start date	2017 Year 05 Month 25 Day
Last follow-up date	2020 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 23 Day
Last modified on	2022 Year 01 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031460