UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of the method for the identification of treatment resistance using hypoxia PET
Title of the study (Brief title)	Identification of treatment resistance using hypoxia PET
Region	Japan

Condition
Condition	head and neck cancer, lung cancer
Classification by specialty	Chest surgery Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Identify the imaging parameters involved in radiation therapy resistance of malignant tumor by comparing them with actual treatment results, and evaluate whether it can be an indicator of response to treatment and prognosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Presence of hypoxic area and time to recurrence in head and neck cancer and lung cancer.
Key secondary outcomes	1) Hypoxic area and PSF, OS 2) Change in tumor marker 3) hypoxic area and LN metastasis, distant metastasis

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	injection of PET tracer(one day, single time)
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.patients with head and neck cancer 2.patients equal to or older than 20 years old 3.Patient who got written informed consent
Key exclusion criteria	1.Lesion has already been surgically resected 2.Breast-feeding, pregnant women, patients wishing for pregnancy 3.Patients judged as not appropriate by researchers
Target sample size	100

Research contact person
Name of lead principal investigator	Shingo Baba
Organization	kyushu University Hospital
Division name	department of radiology
Address	812-8582 3-1-1 Maidashi Higashiku Fukuoka city
TEL	0926425695
Email	sbaba127@radiol.med.kyushu-u.ac.jp

Public contact
Name of contact person	Shingo Baba
Organization	kyushu University Hospital
Division name	department of radiology
Address	812-8582 3-1-1 Maidashi Higashiku Fukuoka city
TEL	0926425695
Homepage URL
Email	sbaba127@radiol.med.kyushu-u.ac.jp

Sponsor
Institute	kyushu University
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)

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 11 Month 10 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 26 Day
Anticipated trial start date	2017 Year 11 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 11 Month 08 Day
Last modified on	2017 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034100