UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017136
Receipt number 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 2019/10/17 08:12:28

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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 or person

Institute

Department of Surgery, Fukushima
Medical University

Institute

Department

Personal name



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

Value
https://center6.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