UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041653 |
|---|---|
| Receipt number | R000047544 |
| Scientific Title | FDG PET/CT for the diagnosis in rectal cancer |
| Date of disclosure of the study information | 2020/09/05 |
| Last modified on | 2020/09/02 14:51:24 |
* 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
FDG PET/CT for the diagnosis in rectal cancer
Acronym
FDG PET/CT for rectal cancer
Scientific Title
FDG PET/CT for the diagnosis in rectal cancer
Scientific Title:Acronym
FDG PET/CT for rectal cancer
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy for the tumor staging and predicting prognosis in rectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy for tumor stating
Key secondary outcomes
The efficacy for predicting prognosis
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pathologically proven rectal cancer
Key exclusion criteria
Uncontrolled diabetes
Not adenocarcinoma
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masatoshi |
| Middle name | |
| Last name | Hotta |
Organization
National Center for Global Health and Medicine
Division name
Nuclear Meicine
Zip code
162-8655
Address
Toyama 1-21-1, Shinjuku-ku, Tokyo
TEL
03-3202-7181
mhotta@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Masatoshi |
| Middle name | |
| Last name | Hotta |
Organization
National Center for Global Health and Medicine
Division name
Nuclear Medicine
Zip code
162-8655
Address
Toyama 1-21-1, Shinjuku-ku, Tokyo
TEL
03-3202-7181
Homepage URL
mhotta@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
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
National Center for Global Health and Medicine
Address
Toyama 1-21-1, Shinjuku-ku, Tokyo
Tel
03-3202-7181
kenkyu-shinsa@hosp.ncgm.go.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
| 2020 | Year | 09 | Month | 05 | Day |
Related information
URL releasing protocol
https://cancerimagingjournal.biomedcentral.com/articles/10.1186/s40644-018-0137-9
Publication of results
Partially published
Result
URL related to results and publications
https://cancerimagingjournal.biomedcentral.com/articles/10.1186/s40644-018-0137-9
Number of participants that the trial has enrolled
59
Results
FDG PET/CT was able to diagnose lymph node metastasis more accurately than MRI.
Results date posted
| 2020 | Year | 09 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patients with rectal cancer who underwent FDG PET/CT
Participant flow
The patients underwent surgery after PET.
Adverse events
None
Outcome measures
The efficacy for the tumor staging
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational cohort study
Management information
Registered date
| 2020 | Year | 09 | Month | 02 | Day |
Last modified on
| 2020 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047544
