UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Early response evaluation of chemotherapy in malignant lymphoma by contrast-enhanced ultrasonography
Title of the study (Brief title)	Contrast-enhanced ultrasonography for malignant lymphoma
Region	Japan

Condition
Condition	malignant lymphoma
Classification by specialty	Hematology and clinical oncology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate predictive value of contrast-enhanced ultrasonography and elastography for early response of chemotherapy in malignant lymphoma, comparison with response rate
Basic objectives2	Others
Basic objectives -Others	Comparison between contrast-enhanced ultrasonographic findings and contrast-enhanced CT findings.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison between some parameters (Time to peak, Area under the curve, etc.) obtained by contrast-enhanced ultrasonography 3, 7, 14 days after start of chemotherapy and response rate.
Key secondary outcomes	Comparison between tissue stiffness obtained by elastography 3, 7, 14 days after start of chemotherapy and response rate.

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) patients with histological confirmed malignant lymphoma 2) target lesion can be depicted by ultrasonography 3) hospiterized patient 4) patients who consented to participate in this study
Key exclusion criteria	1) history of allergy to Sonazoid 2) history of allergy to egg 3) not eligible for this study judged by doctors
Target sample size	50

Research contact person
Name of lead principal investigator	Naoki Matsumoto
Organization	Nihon University School of Medicine, Itabashi Hospital
Division name	Division of Gastroenterology and Hepatology, Department of Medicine
Address	30-1, Oyaguchi kamimachi, Itabashi-ku, Tokyo 173-8610, Japan.
TEL	03-3972-8111
Email	matsumotosg7@gmail.com

Public contact
Name of contact person	Naoki Matsumoto
Organization	Nihon University School of Medicine, Itabashi Hospital
Division name	Division of Gastroenterology and Hepatology, Department of Medicine
Address	30-1, Oyaguchi kamimachi, Itabashi-ku, Tokyo 173-8610, Japan.
TEL	03-3972-8111
Homepage URL
Email	matsumotosg7@gmail.com

Sponsor
Institute	Nihon University School of Medicine, Itabashi Hospital
Institute
Department

Funding Source
Organization	Nihon University School of Medicine, Itabashi Hospital
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 31 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 12 Month 20 Day
Anticipated trial start date	2013 Year 03 Month 05 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	Compare the findings of contrast-enhanced ultrasonography, before and 3, 7, 14 days after start of the chemotherapy for malignant lymphoma

Management information
Registered date	2016 Year 10 Month 29 Day
Last modified on	2016 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028270