UMIN-CTR Clinical Trial

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	Terminated
Date of protocol fixation	2015 Year 03 Month 31 Day
Date of IRB	2017 Year 04 Month 28 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
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	2019 Year 10 Month 17 Day

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