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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024766
Receipt No. R000028492
Scientific Title Application of PET/CT to the molecularly-targeted therapy for thyroid cancer patients
Date of disclosure of the study information 2016/12/01
Last modified on 2016/11/08

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Basic information
Public title Application of PET/CT to the molecularly-targeted therapy for thyroid cancer patients
Acronym PET for TC
Scientific Title Application of PET/CT to the molecularly-targeted therapy for thyroid cancer patients
Scientific Title:Acronym PET for TC
Region
Japan

Condition
Condition thyroid cancer
Classification by specialty
Endocrine surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To address the role of FDG- or MET-PET/CT for the initiation of molecularly-targeted therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes FDG or MET uptake at before and 1 month after the initiation of molecularly-targeted therapy
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 PET/CT examination performed before and 1 month after the molecularly-targeted therapy
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Adult thyroid cancer patients who are scheduled to receive molecularly-targeted therapy at Tokyo Women's Medical University
Key exclusion criteria 1. Pregnant women and women suspected of being pregnant
2. Patients with an incurable malignancy other than thyroid cancer
3. Patients present hyperglycemia (>200 mg/dL)
4. Patients present a poor image quality of PET/CT
5. Patients judged as inadequate trial subjects
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Abe
Organization Tokyo Women's Medical University
Division name Diagnostic Imaging and Nuclear Medicine
Zip code
Address Kawada-cho 8-1, Shinjuku-ku, Tokyo, Lapan
TEL 03-3353-8111
Email abe.koichiro@twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Abe
Organization Tokyo Women's Medical University
Division name Diagnostic Imaging and Nuclear Medicine
Zip code
Address 8-1 Kawad-cho, Shinjuku-ku
TEL 03-3353-8111
Homepage URL
Email abe.koichiro@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Tokyo Women's 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
2016 Year 12 Month 01 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 Preinitiation
Date of protocol fixation
2016 Year 02 Month 29 Day
Date of IRB
Anticipated trial start date
2016 Year 12 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
2016 Year 11 Month 08 Day
Last modified on
2016 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028492

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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