UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017401 |
|---|---|
| Receipt number | R000020186 |
| Scientific Title | Combined Use of 18F-FDG PET and Corticosteroid for Diagnosis of Deep-seated Primary Central Nervous System Lymphoma without Histopathological Confirmation |
| Date of disclosure of the study information | 2015/05/02 |
| Last modified on | 2015/05/02 16:50:19 |
* 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
Combined Use of 18F-FDG PET and Corticosteroid for Diagnosis of Deep-seated Primary Central Nervous System Lymphoma without Histopathological Confirmation
Acronym
PCNSL diagnosis based on FDG PET and corticosteroid
Scientific Title
Combined Use of 18F-FDG PET and Corticosteroid for Diagnosis of Deep-seated Primary Central Nervous System Lymphoma without Histopathological Confirmation
Scientific Title:Acronym
PCNSL diagnosis based on FDG PET and corticosteroid
Region
| Japan |
Condition
Condition
Primary Central Nervous System Lymphoma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In place of a histological diagnosis, the diagnostic adequacy of the combined use of 18F-FDG PET and corticosteroid administration for PCNSL located in a deep-seated brain structure is reported.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy
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
(1) there was no evidence of systemic malignancy
(2) the tumor was located in the deep site of brain, such as in the hypothalamus, brainstem including cerebral peduncle, and cerebellar peduncle, or periventricular infiltration
(3) the tumor had a high FDG uptake on PET, which is defined as when the FDG uptake of lesion is relatively higher than the that of adjacent and contralateral gray matter based on the visual inspection
(4) patients were radiological responders to corticosteroid administration
Key exclusion criteria
any cases which were not matched every inclusion criteria
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Terasaka |
Organization
Hokkaido University
Division name
Department of Neurosurgery
Zip code
Address
North 15 West 7,Kita-ku, Sapporo, Hokkaido
TEL
011-706-5987
terasas@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Yamaguchi |
Organization
Hokkaido University
Division name
Department of Neurosurgery
Zip code
Address
North 15 West 7,Kita-ku, Sapporo, Hokkaido
TEL
011-706-5987
Homepage URL
yama-shu@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Graduate School of Medicine, Hokkaido University
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/25488176
Number of participants that the trial has enrolled
Results
Combining 18F-FDG PET and corticosteroids administration is an important alternative method that may lead to the diagnosis of deep-seated PCNSLs in cases with intractable histopathological confirmations.
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
| 2013 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ten patients (four males and six females) matched these criteria. On pretreatment 18F-FDG PET, mean SUVmax in the tumor was 24.8 (8.75 - 60.75), and mean T/N ratio was 3.24 (2.17 - 5.12). The extent of tumor volume reduction was shown to be 21% to 68% one week after diagnostic therapy by corticosteroids. Nine patients achieved complete response and one patient achieved partial response on MRI after standard treatment for PCNSL with high-dose methotrexate and/or whole-brain irradiation.
Management information
Registered date
| 2015 | Year | 05 | Month | 02 | Day |
Last modified on
| 2015 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020186
