UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017256 |
|---|---|
| Receipt number | R000020014 |
| Scientific Title | New Brain Positron Emission Tomography Scanner with Semiconductor Detectors for Target Volume Delineation and Radiotherapy Treatment Planning in Patients with Nasopharyngeal Carcinoma |
| Date of disclosure of the study information | 2015/04/24 |
| Last modified on | 2015/04/23 20:59:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
New Brain Positron Emission Tomography Scanner with Semiconductor Detectors for Target Volume Delineation and Radiotherapy Treatment Planning in Patients with Nasopharyngeal Carcinoma
Acronym
New brain PET for RT planning in NPC patients
Scientific Title
New Brain Positron Emission Tomography Scanner with Semiconductor Detectors for Target Volume Delineation and Radiotherapy Treatment Planning in Patients with Nasopharyngeal Carcinoma
Scientific Title:Acronym
New brain PET for RT planning in NPC patients
Region
| Japan |
Condition
Condition
Nasopharyngeal Carcinoma
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate effects of the new brain PET system using semiconductor detectors for radiotherapy treatment planning for patients with NPC compared with those of a conventional whole-body BGO PET.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Absolute volumes of gross tumor volume delineated on PET images by using the two types of PET, Dose-volume histogram parameters of the two treatment plans
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Positron Emission Tomography scanner with semiconductor detectors for target volume delineation and radiotherapy treatment planning
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) Nasopharyngeal carcinoma patients who had been newly diagnosed
2) [18F]Fluoro- deoxyglucose-PET images were acquired using both the new brain PET system using semiconductor detectors and conventional whole-body bismuth germanate (BGO) scintillator system on the same day
3) Head and neck CT scan was performed
Key exclusion criteria
Unsuitable for enrollment judged by principal investigator
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norio Katoh |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Radiation Medicine
Zip code
Address
North 15 West 7, Kita-Ku, Sapporo, Hokkaido
TEL
81-11-706-5977
noriwokatoh@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norio Katoh |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Radiation Medicine
Zip code
Address
North 15 West 7, Kita-Ku, Sapporo, Hokkaido
TEL
81-11-706-5977
Homepage URL
noriwokatoh@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Radiation Medicine, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
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
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2010 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2015 | Year | 04 | Month | 23 | Day |
Last modified on
| 2015 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020014
