64Cu-DOTA-B-Fab as A PET Tracer for Evaluating CA6 Expression in Tumors: A First in Human Study

Sanjiv Sam Gambhir1 个研究点分布在 1 个国家目标入组 2 人开始时间: 2016年8月最近更新: 2018年4月5日

适应症

干预措施

试验速览

阶段: 1 期
状态: 终止
发起方
入组人数: 2
试验地点: 1
主要终点: Biodistribution of copper Cu 64 DOTA-B-Fab

研究概览研究设计入排标准研究组 & 干预措施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

This pilot clinical trial studies copper Cu 64-DOTA-B-Fab positron emission tomography (PET)/computed tomography (CT) in imaging patients with ovarian and breast cancer. Cancer antigen (CA)6 is an antigen (substance) found on the surface of several types of cancer cells such as cancer of the ovary and breast. Diagnostic procedures, such as copper Cu 64-DOTA-B-Fab PET/CT, may help identify CA6 positive tumors and allow doctors to plan better treatment.

详细描述

PRIMARY OBJECTIVES:

I. To determine the dosimetry of 64Cu-DOTA B-Fab (copper Cu 64-DOTA-B-Fab).

SECONDARY OBJECTIVES:

I. To evaluate the safety of 64Cu-DOTA B-Fab single administration.

II. To evaluate the ability of 64Cu-DOTA B-Fab to detect CA6-positive ovarian and breast cancer lesions.

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

•Ovarian Cancer Participants
•Patient is ≥ 18 years old at the time of the drug administration
•Participant has suspected or biopsy proven ovarian cancer and is scheduled to undergo surgical excision of the cancerous lesion(s) OR Participant has biopsy proven ovarian cancer but is not a surgical candidate
•Ability to understand and the willingness to sign a written informed consent document.
•Patient is able to remain still for duration of each imaging procedure
•Breast Cancer Participants
•Patient is ≥ 18 years old at the time of the drug administration
•Participant has biopsy proven breast cancer and may or may not undergo surgical excision of the cancerous lesion(s)
•Ability to understand and the willingness to sign a written informed consent document.
•Patient is able to remain still for duration of each imaging procedure

排除标准

•Ovarian Cancer Participants
•Patient is pregnant or breast-feeding
•Patients with contraindications for PET/CT or who cannot complete a PET/CT scan or other study procedures.
•Patients with serious uncontrolled concurrent medical illness that would limit compliance with study requirements
•Patients participating in other research imaging protocols will be excluded from this study.
•Breast Cancer Participants
•Patient is pregnant or breast-feeding
•Patients with contraindications for PET/CT or who cannot complete a PET/CT scan or other study procedures.
•Patients with serious uncontrolled concurrent medical illness that would limit compliance with study requirements
•Patients participating in other research imaging protocols will be excluded from this study.