2022-500918-25-00招募中3 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).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 20
- 主要终点
- 1. Superiority in terms of sensitivity and non-inferiority in terms of specificity of [68Ga]Ga-PTF PET/CT imaging vs. [18F]FDG PET/CT imaging in tumor detection on a lesion-basis confirmed by SoT (central histopathological confirmation of tumor tissue) or surrogate SoT (central evaluation of clinical and imaging follow-up). (Refer to Protocol for complete information)
研究概览
简要总结
- To assess the superiority in terms of sensitivity and non-inferiority in terms of specificity of [68Ga]Ga-PTF PET/CT imaging vs. [18F]FDG PET/CT imaging in tumor detection on a lesion-basis confirmed by a Standard of Truth (SoT; centrally histopathological confirmation of tumor tissue) or surrogate SoT (central evaluation clinical and imaging follow-up).
研究设计
- 分配方式
- Randomized
- 主要目的
- Entire trial period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent form (ICF) from the patient
- •Patients of either gender, aged ≥ 18 years
- •Patients with a histologically proven diagnosis of MZL according to the 4th revised edition of the World Health Organization HAEM4R classification of lymphoid neoplasms as well as established MZL stage. Patients must have a biopsy-proven nodal, extranodal, or splenic MZL (at the time of enrolment, the CXCR4 expression status will be unknown). The biopsy used for MZL diagnosis (diagnostic biopsy) must not be collected more than 12 weeks before Visit
- •Treatment-naïve
- •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
- •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
- •Acceptable organ function (refer to Protocol for complete information)
- •Life expectancy ≥ 12 weeks as estimated by the Investigator
- •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
- •Known hypersensitivity to any active pharmaceutical agent or constituent of the [68Ga]Ga-PTF and/or [18F]FDG product
- •Current greater than grade 2 toxicity from any reason, per US-NCI "Common Terminology Criteria for Adverse Events v5.0" (NCI CTCAE 2017) except if tumor-related
- •Pregnant or breast-feeding women.
- •Colony-stimulating factor (CSF) therapy within 5 days prior to [18F]FDG PET/CT examination.
- •Any recent myocardial infarction, stroke, or osteomyelitis within two months prior screening.
- •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
- •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)
- •Body weight of less than 48 kg
- •Inability to lie still for the entire imaging time
- •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
- •Patients with plasma glucose levels higher than 11 mmol/L or 200 mg/dL prior [18F]FDG administration.
- •Administration of any anticancer therapy within 1 month prior to study entry.
- •Patients with complete resection of the tumor lesion(s)
- •Any other concurrently active neoplasia, or other disease who could jeopardize study safety or data.
- •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
结局指标
主要结局
1. Superiority in terms of sensitivity and non-inferiority in terms of specificity of [68Ga]Ga-PTF PET/CT imaging vs. [18F]FDG PET/CT imaging in tumor detection on a lesion-basis confirmed by SoT (central histopathological confirmation of tumor tissue) or surrogate SoT (central evaluation of clinical and imaging follow-up). (Refer to Protocol for complete information)
1. Superiority in terms of sensitivity and non-inferiority in terms of specificity of [68Ga]Ga-PTF PET/CT imaging vs. [18F]FDG PET/CT imaging in tumor detection on a lesion-basis confirmed by SoT (central histopathological confirmation of tumor tissue) or surrogate SoT (central evaluation of clinical and imaging follow-up). (Refer to Protocol for complete information)
次要结局
- 3. Assessment of the impact on staging of each PET/CT imaging agent.
- 4. Assessment of the impact on the intended treatment plan and patient management of each PET/CT imaging agent.
- 2. Central assessment of the impact on staging of each PET/CT imaging agent.
- 5. Assessment of the percentage of inter-observer agreement of each PET/CT imaging agent local vs. central in terms of staging.
- 6. Local and central assessment of the impact on staging of each PET/CT imaging agent and stratification in MZL subtypes.
- 7. Local and central assessment of the impact on the intended treatment plan and patient management of each PET/CT imaging agent and stratification in MZL subtypes.
- 8. Central assessment of diagnostic performance, consisting of sensitivity and specificity of each PET/CT imaging agent in tumor detection on a region-basis confirmed by SoT.
- 9. Assessment of sensitivity of each PET/CT imaging agent in tumor detection on a patient-basis confirmed by SoT.
- 10. Assessment of diagnostic accuracy of each PET/CT imaging agent to detect tumor lesions on a per patient-basis and lesion-basis confirmed by SoT.
- 11. Determination of PPV and NPV of each PET/CT imaging agent to detect tumor on a patient-basis and lesion-basis.
- 12. Tumor detection rate of each PET/CT imaging agent on a patient-basis and on lesion-basis confirmed by SoT or surrogate SoT.
- 13. Proportion of patients with additional or less lesions detected by [68Ga]Ga-PTF PET/CT imaging compared to [18F]FDG PET/CT imaging.
- 14. Assessment of the percentage of intra- and inter-reader agreement of each PET/CT imaging agent for tumor detection on a lesion-basis, region-basis and patient-basis.
- 15. Evaluation of reproducibility of [68Ga]Ga-PTF PET/CT imaging by comparison of two successive [68Ga]Ga-PTF PET/CT scans in a subpopulation of patients.
- 16. Assessment of the image quality of each PET/CT imaging agent in PET-positive lesions.
- 17. To evaluate the safety and tolerability of each PET/CT imaging agent.
研究者
Clinical trial team
Scientific
Pentixapharm GmbH
研究点 (20)
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