NCT00613847已完成1 期
Biodistribution and Dosimetry of Serial PET Imaging With Ga-68 Labeled F(ab') 2- Trastuzumab
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- the safety & feasibility of PET imaging with radiolabeled 68Ga-F(ab')2-trastuzumab fragments in pts w invasive solid tumors; by using the organ/tissue & body rt dosimetry inform following i.v. injection of 68Ga-F(ab')2-trastuzumab fragments (HERScan)
研究概览
简要总结
The purpose of this study is to learn more about how a new study agent works inside the body. This study agent is a protein called 68Ga-F(ab')2-trastuzumab fragments (HERScan). This is a radioactive tracer that was developed at MSKCC to target the HER2 protein on cancer cells. By giving this tracer to patients whose cancers have the HER2 protein, we hope to be able to see the level of HER2 on the cancer cells using PET scanning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Registered patient at MSKCC
- •Age ≥ or = to 18 years
- •Patients with invasive solid tumors.
- •Measurable or evaluable disease
- •Patients must have had routine disease staging studies with CT scan, FDG PET/CT scan, bone scan and/or MRI within 8 weeks of enrollment onto this trial
- •Karnofsky Performance Score ≥ or = to 60
- •Signed informed consent
排除标准
- •Claustrophobia/pain or any other disability leading to inability to lie still for the duration of the scanning procedure.
- •Pregnancy Test to be performed on female patients of childbearing potential within 24hrs before administration of radioactive material.
- •Patients with known sensitivity or contraindication to Herceptin.
- •Inability to provide written informed consent.
结局指标
主要结局
the safety & feasibility of PET imaging with radiolabeled 68Ga-F(ab')2-trastuzumab fragments in pts w invasive solid tumors; by using the organ/tissue & body rt dosimetry inform following i.v. injection of 68Ga-F(ab')2-trastuzumab fragments (HERScan)
时间窗: conclusion of study
次要结局
- An exploratory objective will be to serially determine tumor uptake of 68Ga-F(ab')2-trastuzumab fragments in a subset of patients with positive scans.(conclusion of study)
- determine the organ/tissue and tumor uptake and localization following i.v. injection of 68Ga-F(ab')2-trastuzumab fragments.(conclusion of study)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast CancerBreast CancerNCT00605397Memorial Sloan Kettering Cancer Center11
已完成
1 期
Study of Kinetics, Dosimetry & Safety of [18F]F-AraG, a Positron Emission Tomography Imaging Tracer in Healthy HumansCancerNCT02323893CellSight Technologies, Inc.6
已完成
早期 1 期
An Imaging Study of 64Cu-SARTATE Using Positron Emission Tomography in Patients With Neuroendocrine TumoursNeuroendocrine TumorsNCT04440956Clarity Pharmaceuticals Ltd10
已完成
1 期
Study of Radiotracer [18F]Fluortriopride ([18F]FTP) by PET/CTHealthyNCT02379338University of Pennsylvania29
终止
1 期
This Study Tests How BI 754111 is Distributed in Patients With Advanced Non-small Cell Lung Cancer or Patients With Head and Neck Cancer Who Are Treated With BI 754091Carcinoma, Non-Small-Cell LungHead and Neck NeoplasmsNCT03780725Boehringer Ingelheim8