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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022592
Receipt No. 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 2020/06/08

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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
Middle name
Last name Satoshi Takeuchi
Organization Hokkaido University Graduate School of Medicine
Division name Department of Medical Oncology
Zip code
Address North 15 West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan
TEL 011-706-5551
Email stakeuch@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Takeuchi
Organization Hokkaido University Graduate School of Medicine
Division name Department of Medical Oncology
Zip code
Address North 15 West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan
TEL 011-706-5551
Homepage URL
Email stakeuch@med.hokudai.ac.jp

Sponsor
Institute Department of Medical Oncology, Hokkaido University Graduate School of Medicine
Institute
Department

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
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 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
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 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
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 03 Day
Last modified on
2020 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025948

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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