UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Early evaluation for chemotherapy response of lung cancer using a new PET/CT tracer of DNA synthesis.
Title of the study (Brief title)	4DST PET/CT for lung cancer chemotherapy
Region	Japan

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

Objectives
Narrative objectives1	To study the diagnostic utility of 4DST PET/CT, as a marker for DNA synthesis, for the early evaluation of chemotherapy response of lung cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	If the tumor uptake reduction of 4DST after chemotherapy is larger and earlier than that of FDG or not.
Key secondary outcomes	The correlation of the tumor uptake reductions of 4DST or FDG after chemotherapy and the tumor volume reduction, and the progression free survival.

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	Medicine
Interventions/Control_1	Before and early after chemotherapy, both FDGPET/CT and 4DST PET/CT will be performed and compared to the clinical parameters. 4DSTPET/CT will be imaged 40min after injection, and FDGPET/CT 1hr after.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients having pathological diagnosis of non-small cell lung cancer, of which stage 3B or 4, or recurrence after surgery. And of whom performance status is 0 or 1, and having enough good hematological and biochemical data tolerable for chemotherapy. And those who have signed the informed consent form.
Key exclusion criteria	Those who have not signed the informed consent form. Those who have symptomatic brain metastasis, or active double cancer, or active infectious disease, or spinal metastasis that required immediate surgery or radiotherapy, or uncontrollable hypertension, or ischemic heart disease, or uncontrollable diabetes. Those who have been decided not appropriate by the physician.
Target sample size	80

Research contact person
Name of lead principal investigator	Ryogo Minamimoto
Organization	National Center for Global Health and Medicine
Division name	Div.Nuclear Medicine, Dept.Radiology
Address	1-21-1 Shinjuku-ku Tokyo, 162-8655 Japan
TEL	03-3202-7181
Email	rminamimoto@hosp.ncgm.go.jp

Public contact
Name of contact person	Ryogo Minamimoto
Organization	National Center for Global Health and Medicine
Division name	Div.Nuclear Medicine, Dept.Radiology
Address	1-21-1 Shinjuku-ku Tokyo, 162-8655 Japan
TEL	03-3202-7181
Homepage URL
Email	rikensa@lily.ocn.ne.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2013 Year 11 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 10 Month 11 Day
Anticipated trial start date	2011 Year 10 Month 11 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 11 Month 17 Day
Last modified on	2017 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014407