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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004170
Receipt No. R000005007
Scientific Title Feasibility study of PET Imaging with 64Cu-DOTA-trastuzumab in HER2 positive breast cancer
Date of disclosure of the study information 2010/09/07
Last modified on 2011/06/28

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Basic information
Public title Feasibility study of PET Imaging with 64Cu-DOTA-trastuzumab in HER2 positive breast cancer
Acronym PET Imaging with Cu-64 Labeled Trastuzumab
Scientific Title Feasibility study of PET Imaging with 64Cu-DOTA-trastuzumab in HER2 positive breast cancer
Scientific Title:Acronym PET Imaging with Cu-64 Labeled Trastuzumab
Region
Japan

Condition
Condition 1. Patients with invasive ductal carcinoma of breast.
2. HER2 positive (IHC 3+> or FISH positive) breast cancer
3. Currently taking or about to commence treatment with trastuzumab or trastumab based chemotherapy
4. Age: >20 years, < 75 years
5. ECOG Performance Score 0 or 1.
6. Good main organ function
7. Capability to be received PET scan.
8. Signed informed consent
Classification by specialty
Hematology and clinical oncology Breast surgery Radiology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The study agent is a protein called 64Cu-DOTA-trastuzumab. In this study the study agent, 64Cu-DOTA-trastuzumab, is the tracer and what's being followed is trastuzumab (Herceptin TM). By giving you this micro-dose 64Cu-DOTA-trastuzumab after you have treatment with trastuzumab, we will be able to use PET scans to show us which parts of your body and tumor sited the Herceptin goes to. We will be also able to detect the localaization of HER2 positive tumor by molecular imaging. The purpose of this study was to determine a feasibility of the assay.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To find recommend dose and schedule of PET scan for molecular imaging by 64Cu-DOTA-trastuzumab.
Key secondary outcomes Second objective: To descover the novel molecular imaging to detect HER2 positive tumor inside the body without needle biopsy.

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
75 years-old >
Gender Female
Key inclusion criteria 1. Patients with invasive ductal carcinoma of breast.
2. HER2 positive (IHC 3+> or FISH positive) breast cancer
3. Currently taking or about to commence treatment with trastuzumab
4. Age: >20 years, < 75 years
5. ECOG Performance Score 0 or 1.
6. Good main organ function
7. Capability to be received PET scan.
8. Signed informed consent
Key exclusion criteria 8. 1.active concomitant malignancy 2.congestive heart failure (CHF)3.uncontrolled angina pectoris, arrhythmia
4.symptomatic infectious disease
5.severe bleeding
6.pulmonary fibrosis
7.obstructive bowel disease or severe diarrhea
8.symptomatic peripheral or cardiac effusion
9.symptomatic brain metastasis.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Tamura
Organization National Cancer Center Hospital
Division name Breast and Medical Oncology div.
Zip code
Address Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Tamura
Organization National Cancer Center Hospital
Division name Breast and Medical Oncology div.
Zip code
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 MHLW (JAPAN)/Reserach for nannchi-gan
Organization
Division
Category of Funding Organization
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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 独立行政法人国立がん研究センター中央病院, 乳腺科・腫瘍内科

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Enrolling by invitation
Date of protocol fixation
2010 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2013 Year 10 Month 01 Day
Date of closure to data entry
2013 Year 10 Month 01 Day
Date trial data considered complete
2013 Year 10 Month 01 Day
Date analysis concluded
2013 Year 12 Month 01 Day

Other
Other related information To determine the regimen of 64Cu-DOTA-Trasutsuzumab

Management information
Registered date
2010 Year 09 Month 07 Day
Last modified on
2011 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005007

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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