UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008557 |
|---|---|
| Receipt number | R000010057 |
| Scientific Title | Comparative study of Indium-111 labeled Pentetreotide (OctreoScan) as somatostatin scintigraphy and FDGPET for the imaging of neuroendocrine tumor and carcinoid tumor. |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2016/04/21 09:14:57 |
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Basic information
Public title
Comparative study of Indium-111 labeled Pentetreotide (OctreoScan) as somatostatin scintigraphy and FDGPET for the imaging of neuroendocrine tumor and carcinoid tumor.
Acronym
Diagnosis of neuroendocrine tumor using OctreoScan and FDGPET.
Scientific Title
Comparative study of Indium-111 labeled Pentetreotide (OctreoScan) as somatostatin scintigraphy and FDGPET for the imaging of neuroendocrine tumor and carcinoid tumor.
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | KUBOTA Kazuo |
Organization
National Center for Global Health and Medicine, Tokyo, Japan
Division name
Department of Nuclear Medicine
Zip code
Address
1-21-1Toyama, Shinjuku-ku, Tokyo162-8655
TEL
03-3202-7181
kkubota@cpost.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | KUBOTA Kazuo |
Organization
National Center for Global Health and Medicine, Tokyo, Japan
Division name
Department of Nuclear Medicine
Zip code
Address
1-21-1Toyama, Shinjuku-ku, Tokyo
TEL
03-3202-7181
Homepage URL
http://www.ncgm.go.jp/sogoannai/housyasen/kakuigaku/inspect/scan.html
rikensa@lily.ocn.ne.jp
Sponsor or person
Institute
Department of Nuclear Medicine, National Center for Global Health and Medicine, Tokyo, Japan
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
http://www.ncgm.go.jp/sogoannai/housyasen/kakuigaku/inspect/scan.html
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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 20 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010057
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
