UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Utility study of PET imaging with 64Cu-DOTA labeled antibody probes against HER2 and EGFR
Title of the study (Brief title)	Cu-DOTA molecular imaging
Region	Japan

Condition
Condition	Breast cancer, Gastric cancer, Colorectal cancer, Glioma
Classification by specialty	Hematology and clinical oncology Gastrointestinal surgery Breast surgery Radiology Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine efficacy and safety of PET imaging with 64Cu-DOTA labeled antibody probes against HER2 and EGFR.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Visualization of PET imaging with 64Cu-DOTA labeled antibody probes against HER2 and EGFR. Comparison between PET imaging and expression of HER2 and EGFR.
Key secondary outcomes	Safety of HER2- and EGFR-PET imaging. Comparison between standardized uptake value on PET imaging and expression of HER2 and EGFR. Comparison between intratumoral uptake of 64Cu-DOTA labeled antibody probes and expression of HER2 and EGFR (in specific cases).

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	64Cu-DOTA labeled antibody probes against HER2 and EGFR
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	25 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients with invasive breast cancer, gastric cancer, colorectal cancer or glioma. 2. Age: >20 years, <75 years 3. ECOG performance status: 0-2 4. Capable of imaging by PET 5. Good main organ function 6. Signed informed consent
Key exclusion criteria	1. Severe drug hypersensitivity 2. Ischemic heart disease, cardiomyopathy, congestive heart failure and uncontrolled arrhythmia 3. Active infectious disease, interstitial pneumonia and pulmonary fibrosis 4. Organ insufficiency (bone marrow, liver and kidney) 5. Active synchronous double cancer 6. Pregnancy and lactating (including possibility and intention) 7. Decision of the physician
Target sample size	200

Research contact person
Name of lead principal investigator	Kenji Tamura
Organization	National Cancer Center Hospital
Division name	Breast and Medical Oncology
Address	Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan
TEL	03-3542-2511
Email	ketamura@ncc.go.jp

Public contact
Name of contact person	Kenji Tamura
Organization	National Cancer Center Hospital
Division name	Breast and Medical Oncology
Address	Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan
TEL	03-3542-2511
Homepage URL
Email	ketamura@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

Funding Source
Organization	JST
Organization
Division
Category of Funding Organization
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	2015 Year 05 Month 08 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 03 Month 31 Day
Anticipated trial start date	2015 Year 05 Month 20 Day
Last follow-up date	2018 Year 03 Month 30 Day
Date of closure to data entry	2018 Year 03 Month 30 Day
Date trial data considered complete	2018 Year 03 Month 30 Day
Date analysis concluded	2019 Year 03 Month 30 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	https://academic.oup.com/annonc/article/28/8/2028/3827471 https://link.springer.com/article/10.1007%2Fs00259-017-3781-6

Management information
Registered date	2015 Year 05 Month 07 Day
Last modified on	2017 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020224