UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparative study of Indium-111 labeled Pentetreotide (OctreoScan) as somatostatin scintigraphy and FDGPET for the imaging of neuroendocrine tumor and carcinoid tumor.
Title of the study (Brief title)	Diagnosis of neuroendocrine tumor using OctreoScan and FDGPET.
Region	Japan

Condition
Condition	Neuroendocrine tumor and carcinoid tumor
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Endocrinology and Metabolism Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Endocrine surgery Radiology Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We will compare the image findings of OctreoScan, representing somatostatin receptor density and FDGPET, representing glucose metabolism, reflecting the grade of malignancy for the diagnosis of neuroendocrine tumor and carcinoid tumor. These two imaging studies will enable evaluation of both the grade of malignancy and differentiation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The target lesion will be determined by history, previous imaging studies, and by CT images at FDGPET/CT. Then, lesion based sensitivity, and the grade of tracer uptake by lesion will be assessed with FDGPET and OctreoScan.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients having neuroendocrine tumor with somatostatin receptor confirmed histologically. Patients having known residual tumor or metastasis by CT scan etc. that can be detected with OctreoScan and FDGPET. Patients who can provide enough medical information including imaging data, histopathology, and treatment history, also can halt somatostatin specific therapy 3 weeks before OctreoScan. Patients with grade 0-2 of performance status(ECOG/WHO), that is from asymptomatic to symptomatic but less than 50% in bed during the day. This clinical research is not sponsored by company etc. Those who want to enter the study must pay by themselves, and sign the informed consent. Please check the information in our homepage.
Key exclusion criteria	Patients having double cancer, or other serious diseases or condition cannot enter the study. Patients who need immediate surgical procedures or radiation therapy cannot enter the study. Pregnant patients cannot enter the study.
Target sample size	30

Research contact person
Name of lead principal investigator	KUBOTA Kazuo
Organization	National Center for Global Health and Medicine, Tokyo, Japan
Division name	Department of Nuclear Medicine
Address	1-21-1Toyama, Shinjuku-ku, Tokyo162-8655
TEL	03-3202-7181
Email	kkubota@cpost.plala.or.jp

Public contact
Name of contact person	KUBOTA Kazuo
Organization	National Center for Global Health and Medicine, Tokyo, Japan
Division name	Department of Nuclear Medicine
Address	1-21-1Toyama, Shinjuku-ku, Tokyo
TEL	03-3202-7181
Homepage URL	http://www.ncgm.go.jp/sogoannai/housyasen/kakuigaku/inspect/scan.html
Email	rikensa@lily.ocn.ne.jp

Sponsor
Institute	Department of Nuclear Medicine, National Center for Global Health and Medicine, Tokyo, Japan
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	国立国際医療研究センター病院（東京都）

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 02 Month 20 Day
Anticipated trial start date	2012 Year 08 Month 01 Day
Last follow-up date	2016 Year 03 Month 15 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	http://www.ncgm.go.jp/sogoannai/housyasen/kakuigaku/inspect/scan.html
Publication of results	Unpublished
URL releasing results
Results
Other related information	The target lesion will be determined by history, previous imaging studies, and by CT images at FDGPET/CT. Then, lesion based sensitivity, and the grade of tracer uptake by lesion will be assessed with FDGPET and OctreoScan.

Management information
Registered date	2012 Year 07 Month 29 Day
Last modified on	2016 Year 04 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010057