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

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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

Primary Central Nervous System Lymphoma

Classification by specialty

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

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

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

Email

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

Email

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

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name