UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034193
Receipt number R000038982
Scientific Title Evaluation of blood flow of malignant tumor using O-15 water PET: the effect of blood flow on therapeutic response
Date of disclosure of the study information 2018/10/01
Last modified on 2023/03/23 10:28:53

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Basic information

Public title

Evaluation of blood flow of malignant tumor using O-15 water PET: the effect of blood flow on therapeutic response

Acronym

Evaluation of blood flow of malignant tumor using O-15 water PET

Scientific Title

Evaluation of blood flow of malignant tumor using O-15 water PET: the effect of blood flow on therapeutic response

Scientific Title:Acronym

Evaluation of blood flow of malignant tumor using O-15 water PET

Region

Japan


Condition

Condition

Lung cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Tumor blood flow is measured using 15 O-water PET for patients with lung cancer before chemotherapy and whether tumor blood flow is a predictive factor of chemotherapy effect will be verified.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Tumor blood flow in patients with lung cancer

Key secondary outcomes



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

Other

Interventions/Control_1

O-15 water PET

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) In our respiratory department internal medicine patient who had lung cancer before chemotherapy with anticancer drug for the first time. However, patients with adjuvant chemotherapy and chemoradiotherapy are excluded. Treatment history of molecular targeted drugs other than chemotherapy with cell-mediated anticancer drugs, surgery, radiotherapy and the like is not limited.
2) Adult patients over the age of 20
3) Patients who have written written consent about their participation in this study at their own will

Key exclusion criteria

1) Patients who are assumed to be difficult to implement this PET examination due to general condition etc.
2) Women who are pregnant
3) Other patients who are judged inappropriate by research researcher, etc.

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Hiroki
Middle name
Last name Kato

Organization

Osaka University Graduate School of Medicine

Division name

Nuclear Medicine and Tracer Kinetics

Zip code

565-0871

Address

2-2 Yamadaoka, Suita, Osaka, 565-0871, JAPAN

TEL

06-6879-3461

Email

kato@tracer.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Tadashi
Middle name
Last name Watabe

Organization

Osaka University Graduate School of Medicine

Division name

Nuclear Medicine and Tracer Kinetics

Zip code

565-0871

Address

2-2 Yamadaoka, Suita, Osaka, 565-0871, JAPAN

TEL

06-6879-3461

Homepage URL


Email

watabe@tracer.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka University School of Medicine Hospital Ethics Committee

Address

2-2 Yamadaoka, Suita, Osaka, 565-0871, JAPAN

Tel

06-6210-8296

Email

rinri@hp-crc.med.osaka-u.ac.jp


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

2018 Year 10 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Open public recruiting

Date of protocol fixation

2018 Year 09 Month 01 Day

Date of IRB

2019 Year 04 Month 12 Day

Anticipated trial start date

2019 Year 05 Month 08 Day

Last follow-up date

2020 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 18 Day

Last modified on

2023 Year 03 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038982


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name