UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035956
Receipt number R000040951
Scientific Title Utility of [11C]4DST PET in assessing malignancy of tumors
Date of disclosure of the study information 2019/02/21
Last modified on 2019/02/20 15:00:59

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Basic information

Public title

Utility of [11C]4DST PET in assessing malignancy of tumors

Acronym

Utility of [11C]4DST PET in assessing malignancy of tumors

Scientific Title

Utility of [11C]4DST PET in assessing malignancy of tumors

Scientific Title:Acronym

Utility of [11C]4DST PET in assessing malignancy of tumors

Region

Japan


Condition

Condition

Brain tumor, head and neck cancer, lung cancer, liver cancer, biliary tract cancer, pancreas cancer, musculoskeletal tumor, prostate cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Pneumology Oto-rhino-laryngology
Orthopedics Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the clinical utility of [11C]4DST PET in characterization and grading of various tumors.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

[11C]4DST uptake in tumors (visual assessment, SUV quantification, uptake count)

Key secondary outcomes

1) histological malignancy
2) FDG uptake in tumors


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

[11C]4DST PET/CT
FDG 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

20 years-old <=

Age-upper limit


 Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients who have malignant tumors or are suspected to have malignant tumors.
2) Patients who agree and write informed consent form

Key exclusion criteria

1) Patients who are assumed to be difficult to implement the PET/CT 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

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiyuki Saginoya

Organization

Southern TOHOKU Research Institute for Neuroscience
Southern TOHOKU Medical Clinic

Division name

PET center

Zip code


Address

7-161 Yatsuyamada, Koriyama, Fukushima

TEL

024-934-5432

Email

toshiyuki.saginoya@mt.strins.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshihiro Eto

Organization

Southern TOHOKU Research Institute for Neuroscience

Division name

Corporate head office

Zip code


Address

7-115 Yatsuyamada, Koriyama, Fukushima

TEL

024-934-5322

Homepage URL


Email

yoshihiro.eto@mt.strins.or.jp


Sponsor or person

Institute

Southern TOHOKU Research Institute for Neuroscience

Institute

Department

Personal name



Funding Source

Organization

Southern TOHOKU Research Institute for Neuroscience

Organization

Division

Category of Funding Organization

Non profit foundation

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

2019 Year 02 Month 21 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

2017 Year 02 Month 17 Day

Date of IRB


Anticipated trial start date

2017 Year 03 Month 03 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

2019 Year 02 Month 20 Day

Last modified on

2019 Year 02 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040951


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name