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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036683
Receipt No. R000041792
Scientific Title Evaluation of Lymph Nodes for Esophageal Cancer by Dynamic FDG-PET
Date of disclosure of the study information 2019/05/08
Last modified on 2019/05/08

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Basic information
Public title Evaluation of Lymph Nodes for Esophageal Cancer by Dynamic FDG-PET
Acronym Evaluation of Lymph Nodes for Esophageal Cancer by Dynamic FDG-PET
Scientific Title Evaluation of Lymph Nodes for Esophageal Cancer by Dynamic FDG-PET
Scientific Title:Acronym Evaluation of Lymph Nodes for Esophageal Cancer by Dynamic FDG-PET
Region
Japan

Condition
Condition Esophageal Cancer
Classification by specialty
Gastrointestinal surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the clinical utility of 18F-FDG pharmacokinetics using dynamic PET/CT scanning in the preoperative assessment of lymph node metastasis in patients with esophageal cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We measure maximum standardized uptake values (SUVmax) of regions of interest at 60 minutes, and also perform pharmacokinetic analysis.
We compare the results of both imaging modalities with the confirmed histopathological diagnoses of each lymph node, and evaluate the diagnostic ability in the detection of lymph node metastasis.
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 Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Patients undergo dynamic scanning in addition to our standard whole-body PET/CT scan at 60 minutes. The dynamic PET acquisition is performed in list-mode, beginning at tracer injection and continuing for 30 minutes.
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)Thoracic esophageal cancer, clinical Stage 0-III(Japanese Clasification of Esophageal Cancer the 11th Edition)
(2)ECOG-PS 0-2
(3)Patients who agree and write informed consent form
Key exclusion criteria (1)Patients who do not comply with fasting, withdrawal and blood sugar standards at our hospital
(2)Patients with much body movement or having severe communication problem
(3)Pregnant woman, breastfeeding mother and woman who may be pregnant
(4)Patients with a history of hypersensitivity for 18F-FDG
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Kamei
Organization Tohoku University Hospital
Division name Department of Surgery
Zip code 9808574
Address 1-1, Seiryo-machi, Aoba-ku, Sendai
TEL 0227177214
Email tkamei@surg.med.tohoku.ac.jp

Public contact
Name of contact person
1st name Kozue
Middle name
Last name Takahashi
Organization Tohoku University Hospital
Division name Department of Surgery
Zip code 9808574
Address 1-1, Seiryo-machi, Aoba-ku, Sendai
TEL 0227177214
Homepage URL
Email kozuet@surg.med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

Funding Source
Organization University grants of Tohoku University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization JPN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tohoku University, Department of Surgery
Address 1-1, Seiryo-machi, Aoba-ku, Sendai
Tel 0227177214
Email kozuet@surg.med.tohoku.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

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 08 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
2019 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 08 Day
Last follow-up date
2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 08 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041792

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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