UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024766 |
|---|---|
| Receipt number | 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 20:49:26 |
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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
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
abe.koichiro@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028492
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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