UMIN-CTR Clinical Trial

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
Last 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
1st 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