NL-OMON44943已完成不适用
PET imaging of [18F]dabrafenib distribution and kinetics in brain metastasis. - [18F]dabrafenib molecular imaging
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Has signed informed consent.
- •2. Older than 18 years of age.
- •3. Histologically confirmed cutaneous metastatic melanoma (Stage IV), including confirmed brain metastases.
- •4. BRAF mutation-positive (V600 E/K) melanoma as determined by standardized genetic testing.
- •5. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
- •6. Eligible for standard treatment with dabrafenib.
- •7. No contraindication for performing a CT scan.
- •8. No contraindication for performing a MRI scan of the brain.
- •9. Women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control from 14 days prior to randomization, throughout the treatment period and for 4 weeks after the last dose of study treatment.
- •10. Women of child-bearing potential must have a negative serum pregnancy test (*-HCG) within 14 days of first dose of study treatment.
排除标准
- •1. Treatment with a BRAF or MEK inhibitor.
- •2. Known immediate or delayed hypersensitivity reaction to dabrafenib or excipients.
- •3. Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study treatment and during the study.
- •4. Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. Grade 2 or higher from previous anti-cancer therapy, except alopecia.
- •5. Any serious or unstable pre-existing medical conditions (i.e, diabetes mellitus, hypertension, etc), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol.
- •6. Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent, unless a legally acceptable representative could provide informed consent.
- •7.Pregnant or nursing females.
研究者
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