UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004444 |
|---|---|
| Receipt number | R000005314 |
| Scientific Title | Tumor imaging using 68Ga-octreotide |
| Date of disclosure of the study information | 2011/01/01 |
| Last modified on | 2016/02/09 08:59:19 |
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Basic information
Public title
Tumor imaging using 68Ga-octreotide
Acronym
Somatostatin receptor scintigaraphy
Scientific Title
Tumor imaging using 68Ga-octreotide
Scientific Title:Acronym
Somatostatin receptor scintigaraphy
Region
| Japan |
Condition
Condition
neuroendocrine tumor
non-FDG-avid tumor
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Endocrine surgery |
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical usefulness of PET/CT with 68Ga-DOTA-TOC
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic accuracy and clinical impact of PET/CT with 68Ga-DOTA-TOC
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 | Device,equipment |
Interventions/Control_1
68Ga-DOTA-TOC, which is synthesized in our institute, is intravenously administered. 30-60 min later, whole body scanning is performed using an inline PET/CT system.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are suspected of having tumors with somatostatin receptors, and are requested for localization, staging or restaging, and moinitoring therapy response.
Key exclusion criteria
1. Communication disturbance
2. Extremely poor physical status
3. Informed consent not available
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Nakamoto |
Organization
Kyoto University Hospital
Division name
Department of Diagnostic Radiology
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3538
ynakamo1@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Nakamoto |
Organization
Kyoto University Hospital
Division name
Department of Diagnostic Radiology
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto
TEL
075-751-3538
Homepage URL
ynakamo1@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM RI Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
京都大学医学部附属病院(京都府)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 26 | Day |
Last modified on
| 2016 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005314
