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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006898
Receipt No. R000006222
Scientific Title Hypoxia imaging in lung cancer patients utilizing62Cu-ATSM-PET/CT with reference to histopathology.
Date of disclosure of the study information 2011/12/17
Last modified on 2011/12/17

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Basic information
Public title Hypoxia imaging in lung cancer patients utilizing62Cu-ATSM-PET/CT with reference to histopathology.
Acronym Hypoxia imaging in lung cancer patients utilizing62Cu-ATSM-PET/CT with reference to histopathology.
Scientific Title Hypoxia imaging in lung cancer patients utilizing62Cu-ATSM-PET/CT with reference to histopathology.
Scientific Title:Acronym Hypoxia imaging in lung cancer patients utilizing62Cu-ATSM-PET/CT with reference to histopathology.
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate clinical usefulness of ATSM PET for patients with primary lung cancer who are scheduled to receive curative resection.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes safety
Key secondary outcomes The accumulation of ATSM at the tumor

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 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) The case who was diagnosed as primary lung cancer either pathologically or cytologically.
2) The case who was scheduled to receive a curative resection.
3) The case to whom iodine contrast media can be injected.
4) The case who gave the written consent to join the study.
5) The case whose PS is between 0 and 2, the case who suffers from a serious illness except malignancy and the case who will become pregnant.
Key exclusion criteria 1) The case who is difficult to be included in the study due to psychological disorder and so on.
2) The case to whom the test agent cannot be injected due to iodine allergy and so on.
3) The case who is judged by the physician in charge not to be included in the study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yotaro Izumi
Organization Schoolof Medicine, Keio University
Division name General Thoracic Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization School of Medicine, Keio University
Division name General Thoracic Surgery
Zip code
Address
TEL 03-5363-3806
Homepage URL
Email

Sponsor
Institute School of Medicine, Keio University
Institute
Department

Funding Source
Organization Grant in aid from the Japanese Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 12 Month 17 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
2011 Year 03 Month 11 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 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
2011 Year 12 Month 17 Day
Last modified on
2011 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006222

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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