UMIN-CTR Clinical Trial

Basic information
Public title	The usefulness of Cu-62 ATSM PET/CT to evaluate the sensitivity to radiotherapy for lung cancer and head and neck cancer
Acronym	The evaluation of the sensitivity to radiotherapy by Cu-62 ATSM PET/CT
Scientific Title	The usefulness of Cu-62 ATSM PET/CT to evaluate the sensitivity to radiotherapy for lung cancer and head and neck cancer
Scientific Title:Acronym	The evaluation of the sensitivity to radiotherapy by Cu-62 ATSM PET/CT
Region	Japan

Condition
Condition	Lung cancer and head and neck cancer
Classification by specialty	Pneumology Chest surgery Oto-rhino-laryngology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the usefulness of Cu-62 ATSM PET/CT to predict the sensitivity to radiotherapy for lung cancer and head and neck cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Accumulation of Cu-62 ATSM in the tumor
Key secondary outcomes

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	Cu-62 ATSM PET/CT
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)non-small cell lung cancer or head and neck cancer (pathologically or cytologically proven) 2)Radiotherapy or chemoradiotherapy is scheduled. 3)Iodine contrast media can be administered 4)Written informed concent was obtained. 5)PS 0-2, no severe complication besides malignancy, no pregnancy 6)AST ULNx2.5, ALT ULNx2.5, T.bil 2.0mg/dl, Serum creatinine 1.5mg/dl
Key exclusion criteria	1) Patient under the psychological condition 2) Patient to whom imaging agents cannot be injected 3) Patient who was judged as unsuitable by the doctor
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hirofumi Middle name Last name Fujii
Organization	National Cancer Center
Division name	Division of Functional Imaging
Zip code	277-8577
Address	6-5-1 Kashiwanoha, Kashiwa
TEL	04-7134-6831
Email	fujii-rad@umin.org

Public contact
Name of contact person	1st name Hirofumi Middle name Last name Fujii
Organization	National Cancer Center
Division name	Division of Functional Imaging
Zip code	277-8577
Address	6-5-1 Kashiwanoha, Kashiwa
TEL	04-7134-6831
Homepage URL
Email	hifujii@ncc.go.jp

Sponsor
Institute	National Cancer Center
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Office for Research Ethics, National Cancer Center
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045
Tel	03-3542-2511 EXT. 2597
Email	NCC_IRBoffice@ml.res.ncc.go.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	2011 Year 05 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	47
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2010 Year 12 Month 24 Day
Date of IRB	2008 Year 04 Month 17 Day
Anticipated trial start date	2010 Year 12 Month 01 Day
Last follow-up date	2018 Year 03 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 05 Month 17 Day
Last modified on	2020 Year 11 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006636