CTIS2022-500918-25-00招募中1 期
A pivotal phase 3 clinical trial to assess the diagnostic performance and safety of [68Ga]Ga-PentixaFor ([68Ga]Ga-PTF), a positron emission tomography (PET) imaging agent, versus [18F]FDG PET/CT imaging, for staging of patients with confirmed marginal zone lymphoma (MZL) exemplary for CXCR4-positive malignant lymphomas: a prospective, international, multi-center, comparative, randomized, cross-over, open-label lymphoma diagnostic trial (LYMFOR). - PTF301
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 148
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 65+（—）
- 性别
- All
入选标准
- •1. Signed informed consent form (ICF) from the patient, 2. Patients of either gender, aged = 18 years, 3. Patients with a histologically proven diagnosis of MZL according to the World Health Organization classification of lymphoid neoplasms. Patients must have a biopsy-proven nodal, extranodal, or splenic MZL (at the time of enrolment, the CXCR4 expression status will be unknown), 4. Treatment-naïve, 5. Negative pregnancy test in women capable of child-bearing and their agreement to use highly effective contraception for 1 month after the last dose of [68Ga]Ga-PTF and [18F]FDG, 6. For male patients whose partner is of child-bearing potential: The patient is willing to ensure that he and his partner use effective contraception for 1 month after the last dose of [68Ga]Ga-PTF and [18F]FDG, 7. Acceptable organ function (refer to Protocol for complete information), 8. Life expectancy = 12 weeks as estimated by the Investigator, 9. The patient must not have undergone any physical or pharmacological intervention with curative or palliative intent between the time of any of the diagnostic measures and the [68Ga]Ga-PTF PET/CT and [18F]FDG PET/CT scan
排除标准
- •1. Known hypersensitivity to any active pharmaceutical agent or constituent of the [68Ga]Ga-PTF and/or [18F]FDG product, 7. Administration of another investigational medicinal product within 30 days or within 5 terminal elimination half-lives of a previous investigational medicinal product, whichever is longer, prior to study entry, 8. Current greater than grade 2 toxicity from any reason, per US-NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE version 5.0) except if tumor-related, 9. Pregnant or breast-feeding women., 11. Colony-stimulating factor (CSF) therapy within 5 days prior to [18F]FDG PET/CT examination., 12. Any recent myocardial infarction, stroke, or osteomyelitis within two months prior screening., 13. [18F]FDG PET/CT imaging performed prior to study entry., 10. Concomitant prohibited treatment which may interfere with [68Ga]Ga-PTF PET/CT imaging (systemic corticosteroids) administered within the last 1 month prior to study start, 14. Judged by the referring physician as not mentally or as not physically fit to understand and comply with protocol-related interventions and procedures (e.g., medically retarded, body weight > 180 kg for PET scanner), 15. Body weight of less than 48 kg, 2. Inability to lie still for the entire imaging time, 3. Any severe acute or active chronic infection, as judged by the Investigator, at the time of screening or within two months prior to screening that may interfere with the diagnostic properties of [68Ga]Ga-PTF PET/CT or [18F]FDG PET/CT imaging, 4. Patients with plasma glucose levels higher than 11 mmol/L or 200 mg/dL prior [18F]FDG administration., 5. Administration of any anticancer therapy within 1 month prior to study entry., 6. Patients with complete resection of the tumor lesion(s)
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