UMIN ID: UMIN000004170
Registered date:07/09/2010
Feasibility study of PET Imaging with 64Cu-DOTA-trastuzumab in HER2 positive breast cancer
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | 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 |
| Date of first enrollment | 2010/10/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | To find recommend dose and schedule of PET scan for molecular imaging by 64Cu-DOTA-trastuzumab. |
|---|---|
| Secondary Outcome | Second objective: To descover the novel molecular imaging to detect HER2 positive tumor inside the body without needle biopsy. |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Female |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | National Cancer Center Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | MHLW (JAPAN)/Reserach for nannchi-gan |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kenji Tamura |
| Address | Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan Japan |
| Telephone | 03-3542-2511 |
| ketamura@ncc.go.jp | |
| Affiliation | National Cancer Center Hospital Breast and Medical Oncology div. |
| scientific contact | |
| Name | Kenji Tamura |
| Address | Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan Japan |
| Telephone | 03-3542-2511 |
| Affiliation | National Cancer Center Hospital Breast and Medical Oncology div. |