UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036683 |
|---|---|
| Receipt number | 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 15:47:08 |
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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
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
kozuet@surg.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041792
