UMIN ID: UMIN000033617
Registered date:03/08/2018
5-ALA and VLD-EX guided resection of malignant brain tumor
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Malignant brain tumor |
| Date of first enrollment | 2012/11/14 |
| Target sample size | 160 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Detection of PpIX by VLD-EX after intake of 5-ALA 20mg/kg |
Outcome(s)
| Primary Outcome | Detection rate of PpIX under white light |
|---|---|
| Secondary Outcome | Detection rate of PpIX Adverse events |
Key inclusion & exclusion criteria
| Age minimum | 15years-old |
|---|---|
| Age maximum | 90years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1)Porphyria or orphyrin hypersensitivity 2) Cr >= 2.0 3) ALT >= 100, AST >= 100, TB >= 3.0 4) Patient with other malignant tumor 5) Pregnant or lactating woman |
Related Information
| Primary Sponsor | National Cancer Center Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | National Cancer Center Hospital |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yoshitaka Narita |
| Address | 5-1-1 Tsukiji Chuo-ku, Tokyo Japan |
| Telephone | 03-3542-2511 |
| yonarita@ncc.go.jp | |
| Affiliation | National Cancer Center Hospital Department of Neurosurgery and Neuro-Oncology |
| scientific contact | |
| Name | Yoshitaka Narita |
| Address | 5-1-1 Tsukiji Chuo-ku, Tokyo Japan |
| Telephone | 03-3542-2511 |
| yonarita@ncc.go.jp | |
| Affiliation | National Cancer Center Hospital Department of Neurosurgery and Neuro-Oncology |