UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Amide proton transfer imaging for malignant brain tumor and spinal tumor
Title of the study (Brief title)	Amide proton transfer imaging for malignant brain tumor and spinal tumor
Region	Japan

Condition
Condition	Malignant brain tumor, spinal tumor
Classification by specialty	Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical usefulness of amide proton transfer imaging (APT imaging) in the management of malignant brain tumors and spinal tumors
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between APT image and cellularity and mitotic activity
Key secondary outcomes	1. Comparison between APT image and diffusion weighted image and Positron emission tomography (PET) image 2. Correlation between early change of APT image after chemoradiotherapy and progression free survival time and overall survival time

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who will undergo surgical resection, or chemotherapy or radiotherapy for malignant brain tumor or spinal tumor 2. Patients with written informed consent
Key exclusion criteria	1. Patients with heart pacemaker 2. Patients with metallic foreign body, such as cochlea implant, etc. 3. Patients with severe claustrophobia 4. Patients who may not keep rest on the bed
Target sample size	80

Research contact person
Name of lead principal investigator	Yoshitaka Narita
Organization	National Cancer Center Hospital
Division name	Department of Neurosurgery and Neuro-Oncology
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL	03-3542-2511
Email	yonarita@ncc.go.jp

Public contact
Name of contact person	Makoto Ohno
Organization	National Cancer Center Hospital
Division name	Department of Neurosurgery and Neuro-Oncology
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL	03-3542-2511
Homepage URL
Email	mohno@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

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)

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	国立がん研究センター中央病院

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 15 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 10 Month 31 Day
Anticipated trial start date	2017 Year 11 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We investigate whether APT signal intensity are correlated with tumor cell-density and proliferation activity. We perform longitudinal APT imaging study to assess the treatment response during the clinical course.

Management information
Registered date	2018 Year 01 Month 13 Day
Last modified on	2018 Year 01 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035157