Unique ID issued by UMIN | UMIN000004170 |
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Receipt number | 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 12:43:27 |
Feasibility study of PET Imaging with 64Cu-DOTA-trastuzumab in HER2 positive breast cancer
PET Imaging with Cu-64 Labeled Trastuzumab
Feasibility study of PET Imaging with 64Cu-DOTA-trastuzumab in HER2 positive breast cancer
PET Imaging with Cu-64 Labeled Trastuzumab
Japan |
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
Hematology and clinical oncology | Breast surgery | Radiology |
Malignancy
YES
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.
Safety
Exploratory
Not applicable
To find recommend dose and schedule of PET scan for molecular imaging by 64Cu-DOTA-trastuzumab.
Second objective: To descover the novel molecular imaging to detect HER2 positive tumor inside the body without needle biopsy.
Observational
20 | years-old | <= |
75 | years-old | > |
Female
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
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.
40
1st name | |
Middle name | |
Last name | Kenji Tamura |
National Cancer Center Hospital
Breast and Medical Oncology div.
Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan
03-3542-2511
1st name | |
Middle name | |
Last name | Kenji Tamura |
National Cancer Center Hospital
Breast and Medical Oncology div.
Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan
03-3542-2511
ketamura@ncc.go.jp
National Cancer Center Hospital
MHLW (JAPAN)/Reserach for nannchi-gan
NO
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
2010 | Year | 09 | Month | 07 | Day |
Unpublished
Enrolling by invitation
2010 | Year | 09 | Month | 07 | Day |
2010 | Year | 10 | Month | 01 | Day |
2013 | Year | 10 | Month | 01 | Day |
2013 | Year | 10 | Month | 01 | Day |
2013 | Year | 10 | Month | 01 | Day |
2013 | Year | 12 | Month | 01 | Day |
To determine the regimen of 64Cu-DOTA-Trasutsuzumab
2010 | Year | 09 | Month | 07 | Day |
2011 | Year | 06 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005007
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