UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029884 |
|---|---|
| Receipt number | R000034100 |
| Scientific Title | Development of the method for the identification of treatment resistance using hypoxia PET |
| Date of disclosure of the study information | 2017/11/10 |
| Last modified on | 2017/11/08 14:57:01 |
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Basic information
Public title
Development of the method for the identification of treatment resistance using hypoxia PET
Acronym
Identification of treatment resistance using hypoxia PET
Scientific Title
Development of the method for the identification of treatment resistance using hypoxia PET
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Shingo Baba |
Organization
kyushu University Hospital
Division name
department of radiology
Zip code
Address
812-8582 3-1-1 Maidashi Higashiku Fukuoka city
TEL
0926425695
sbaba127@radiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Baba |
Organization
kyushu University Hospital
Division name
department of radiology
Zip code
Address
812-8582 3-1-1 Maidashi Higashiku Fukuoka city
TEL
0926425695
Homepage URL
sbaba127@radiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
kyushu University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Preinitiation
Date of protocol fixation
| 2017 | Year | 10 | Month | 26 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034100
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| Registered date | File name |
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