临床试验/NCT04054986

NCT04054986已完成1 期

Phase 1 Study Using First-in-Human Acidosis Imaging With [18F]AlF-cysVar3 pHLIP® (18F-Var3) in Patients With Breast Cancer for Determination of Safety, Biodistribution and Radiation Dosimetry

Memorial Sloan Kettering Cancer Center1 个研究点分布在 1 个国家目标入组 6 人开始时间: 2019年8月9日最近更新: 2025年5月16日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Memorial Sloan Kettering Cancer Center
入组人数: 6
试验地点: 1
主要终点: Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to measure the safety of the investigational imaging agent, 18F-Var3 and to determine if it is helpful in providing information about how tumor tissues behave.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Diagnostic
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Age 18 years or greater
•Biopsy-proven breast malignancy
•>/= 1 viable lesion, >/= 1 cm, confirmed on CT, MR, or FDG PET/CT within 4 weeks of protocol enrollment
•Newly diagnosed or recurrent disease, on or off therapy
•ECOG performance of 0-2 *Note: Lesions are considered viable if they are stable or increasing soft tissue lesions, or if they are FDG-avid bone lesions

排除标准

•Life expectancy < 3 months
•Pregnancy or lactation
•Biopsy or other surgical procedures within 48 hours prior to receiving study intervention
•Patients who cannot undergo PT/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 400 pounds

结局指标

主要结局

Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0

时间窗: 30 days after completion of study treatment and assessments

The safety of patients will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 1 and grade 2 toxicities are considered safe.

次要结局

未报告次要终点

研究者

发起方

Memorial Sloan Kettering Cancer Center

申办方类型

Other

责任方

Sponsor

研究点 (1)

Loading locations...

相似试验

撤回

1 期

18-F-Fluoroacetate as PET Imaging AgentBrain CancerBreast CancerProstate Cancer

NCT01320787M.D. Anderson Cancer Center

尚未招募

1 期

MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain TumorsHealthy VolunteersRecurrent Glioma

NCT05676489University of Alabama at Birmingham28

终止

1 期

A Trial of 18F-AV-133 Positron Emission Tomography (PET)Type 2 DiabetesType 1 Diabetes

NCT01515384Avid Radiopharmaceuticals19

已完成

1 期

Dose-escalation Study of a Contrast Agent for Delineation of Urological Anatomy in Minimally Invasive SurgeryIntraoperative Ureter Injury

NCT03106038Li-Cor, Inc.41

已完成

1 期

A Phase I Study to Evaluate XTR003 in Healthy Chinese VolunteersCoronary Artery Disease (CAD)

NCT05136391Sinotau Pharmaceutical Group10