UMIN ID: UMIN000026658
Registered date:24/03/2017
64Cu-DOTA-nivolumab PET imaging in patients with malignant melanoma or non-small cell lung cancer.
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | Unresectable or metastatic malignant melanoma,unresectable or metastatic non small cell lung cancer |
| Date of first enrollment | 2017/03/24 |
| Target sample size | 50 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Drug: 64Cu-DOTA-nivolumab Device: 64Cu-DOTA-nivolumab PET |
Outcome(s)
| Primary Outcome | Sensitivity; proportion of 64Cu-DOTA-nivolumab PET positive patients within PD-1 positive tumors. Specificity; proportion of 64Cu-DOTA-nivolumab PET negative patients within PD-1 negative tumors. |
|---|---|
| Secondary Outcome | Feasibility of 64Cu-DOTA-nivolumab PET imaging Positive predive predictive value and negative predictive value of 64Cu-DOTA-nivolumab PET imaging |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Previous any drug allergies. 2. Uncontrolled any comorbidities (eg; cardiovascular disease, diabetes and psychiatric disease) 3. Active systemic infectious disease 4. Previous history of interstitial lung disease or pulmonary fibrosis disease. 5. Pregnant or lactating women. 6. Patients who recognized inappropriate candidate by physician. |
Related Information
| Primary Sponsor | National Cancer Center Hospital, Tokyo, Japan |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Japan Agency for Medical Research and Development Ono Pharmaceutical Co., Ltd. Bristol-Myers Squibb Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Asuka Kawachi/ Akihiko Shimomura |
| Address | 5-1-1, Chuo-ku, Tsukiji, Tokyo, Japan Japan |
| Telephone | 03-3542-2511 |
| akawachi@ncc.go.jp | |
| Affiliation | National Cancer Center Hospital, Tokyo, Japan Breast and Medical Oncology |
| scientific contact | |
| Name | Kenji Tamura |
| Address | 5-1-1, Chuo-ku, Tsukiji, Tokyo, Japan Japan |
| Telephone | 03-3542-2511 |
| ketamura@ncc.go.jp | |
| Affiliation | National Cancer Center Hospital, Tokyo, Japan Breast and Medical Oncology |