UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022592 |
|---|---|
| Receipt number | R000025948 |
| Scientific Title | Evaluation of early prediction using 18F-FDG PET/CT for patients with Iodine-131 refractory differentiated thyroid carcinoma treated with lenvatinib |
| Date of disclosure of the study information | 2016/06/06 |
| Last modified on | 2022/12/08 17:22:22 |
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Basic information
Public title
Evaluation of early prediction using 18F-FDG PET/CT for patients with Iodine-131 refractory differentiated thyroid carcinoma treated with lenvatinib
Acronym
Early Prediction using 18F-FDG PET/CT for patients with differentiated thyroid carcinoma treated with lenvatinib
Scientific Title
Evaluation of early prediction using 18F-FDG PET/CT for patients with Iodine-131 refractory differentiated thyroid carcinoma treated with lenvatinib
Scientific Title:Acronym
Early Prediction using 18F-FDG PET/CT for patients with differentiated thyroid carcinoma treated with lenvatinib
Region
| Japan |
Condition
Condition
differentiated thyroid carcinoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of early prediction by 18F-FDG PET/CT for patients with Iodine-131 refractory differentiated thyroid carcinoma treated with lenvatinib
Basic objectives2
Others
Basic objectives -Others
To analyze other early predictors of treatment outcome
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Receiver Operating Characteristic-Area Under the Curve obtained by 18-FDG PET/CT performed 1 week after initiation of therapy with lenvatinib compared with conventional CT
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
18F-FDG PET/CT is supposed to underwent 1 week after initiation of therapy with lenvatinib
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients to be treated with lenvatinib
2) Patients more than 18 years old.
3) Histologically confiremed differentiated thyroid carcinoma
4) Iodine-131 refractory
5) Appropriate physical status
5) Patients with written informed consent
Key exclusion criteria
1) Medullary or undifferentiated thyroid carcinoma
2) Ever treated with chemotherapy
3) Double cancer
4) Poor physical status
5) Severe complication
6) Fasting blood glucose over 150 mg/dl
7) Brain metastasis or vascular thrombus requiring treatment
8) Inappropriate to perform 18F-FDG PET/CT or CT due to complications
9) Pregnanant or nursing woman
10) Other inappropriate patients judged byinvestigators
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Takeuchi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Medical Oncology
Zip code
0608638
Address
North 15 West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan
TEL
011-706-5551
stakeuch@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Takeuchi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Medical Oncology
Zip code
0608638
Address
North 15 West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan
TEL
011-706-5551
Homepage URL
stakeuch@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Medical Oncology, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital
Address
North 15 West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan
Tel
011-701-7636
crjimu@huhp.hokudai.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
北海道大学、斗南病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 06 | 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
22
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to delay of data analyzing
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 09 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 03 | Day |
Last modified on
| 2022 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025948
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