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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017136
Receipt No. R000019875
Scientific Title A pilot study of clinical usefulness of PET-CT and PET-MRI in cancer patients treated with medical tharapy
Date of disclosure of the study information 2015/04/14
Last modified on 2015/04/14

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Basic information
Public title A pilot study of clinical usefulness of PET-CT and PET-MRI in cancer patients treated with medical tharapy
Acronym Clinical usefulness of PET-CT and PET-MRI in cancer medical tharapy
Scientific Title A pilot study of clinical usefulness of PET-CT and PET-MRI in cancer patients treated with medical tharapy
Scientific Title:Acronym Clinical usefulness of PET-CT and PET-MRI in cancer medical tharapy
Region
Japan

Condition
Condition Cancer
Classification by specialty
Surgery in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Study of clinilal usefullness of PET-CT and PET-MRI in cancer patients treated with medical tharapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes response rate
Key secondary outcomes clinical benefit rate

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Cancer medical tharapy
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1.Case signedinformed consent of the
patients for the registration
2.Case confirmed by pathological diagnosis
3.younger than 85 years old, 20 years old or older
4.Case planned for cancer treatment of chemothareapy, hormone tharapy, or targeted therapy
5.Case with measurable primary lesions
6.Case that survival more than 6 months isanticipated
7.Case with PS 0 or 1
8.Case with a satisfactory function of a
heart/liver/kidney/bone marrow ant to
satisfy the next condition
Hb:more than 8g/dl
AST(GOT), ALT(GPT):less than 2.5 times of
the normal value upper limit of the institution
Crea:less than 1.5 mg/dl
Key exclusion criteria 1.Case with active other malignancies
2.Case with past history of drug allergy or
hypersensitivity
3.Case during pregnancy or lactation
4.Case with a history of operation of A cerebral aneurysm, a cardiac pacemaker, or a internal metal
5.Case with infectious disease
6.Case judged inappropriate by physicians
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tohru Ohtake
Organization Fukushima Medical University
Division name Department of Surgery
Zip code
Address 1 Hikariga-oka Fukushima
TEL 024-547-1259
Email trcyn@cc.fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Abe
Organization Fukushima Medical University
Division name Department of Surgery
Zip code
Address 1 Hikariga-oka Fukushima
TEL 024-547-1259
Homepage URL
Email abenori2@fmu.ac.jp

Sponsor
Institute Department of Surgery, Fukushima
Medical University
Institute
Department

Funding Source
Organization Department of Surgery, Fukushima
Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2015 Year 04 Month 14 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 Enrolling by invitation
Date of protocol fixation
2015 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 06 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
2015 Year 04 Month 14 Day
Last modified on
2015 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019875

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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