A Pilot Study of Tc-94m Sestamibi PET MDR Imaging
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Percent Change in Tc-94m Sestamibi Body Weight Standardized Uptake Value (SUV) Maximum in Tumor Tissue Before and After Administration of Tariquidar, a P-glycoprotein Antagonist.
研究概览
简要总结
Background:
- Tc-94m sestamibi is a radioactive imaging drug approved by the Food and Drug Administration to help photograph and study bodily functions.
- Tc-94m sestamibi accumulates in tumor cells and is eliminated from them in much the same way that some chemotherapy drugs are eliminated from cancer cells in patients with drug resistance.
- P-glycoprotein is a protein found on the surface of some cancer cells. The protein causes the cells to pump out, or reject, some types of chemotherapy drugs. P-glycoprotein also makes the cells reject sestamibi.
- Some drugs, including a drug called tariquidar, may block the pumping action of P-glycoprotein, giving the chemotherapy more time to work. Tariquidar can also help sestamibi stay in the cells longer.
Objectives:
-To evaluate the use of sestamibi for determining if chemotherapy is being rejected and if enough of the blocking drugs are present to stop the rejection.
Eligibility:
-Patients18 years of age and older with a tumor 2 cm or larger who are enrolled in or are eligible for enrollment in an active National Cancer Institute treatment protocol.
Design:
- Patients have two scans, one before receiving any drugs and a second 1-2 hours after receiving tariquidar. The second scan is done 72 or more hours after the first. For both scans, Tc-94m sestamibi is injected into a vein and a series of pictures are taken with an imaging camera called a PET (positron emission tomography) scanner. The pictures show where the sestamibi distributes in the body and monitors the effects of tariquidar on drug resistance. Blood samples are collected during the scan to examine the effect of tariquidar on P-glycoprotein in normal cells.
- Some patients may be asked to undergo a tumor biopsy to test for the presence of the P-glycoprotein on their cancer cells. This will be requested only in patients whose tumor is easily accessible and in whom a biopsy can be done with minimal risk.
详细描述
Background:
- A pilot study of PET imaging with Tc-94m sestamibi to assess activity of the multidrug transporter, MDR-1 (Multi Drug Resistance Protein 1)/P-glycoprotein, an ATP (adenosine 5'-triphosphate)-binding cassette protein that transports drug out of the cell, thereby reducing intracellular drug accumulation.
- Tariquidar is a safe, nontoxic antagonist of P-glycoprotein. Previous studies demonstrated that tariquidar increased retention of the radioimaging agent, Tc99 sestamibi in normal liver and in a subset of tumors. These studies were limited by the semiquantitative nature of total body imaging by conventional radionuclide scintigraphy
- In collaboration with the Clinical Center Nuclear Medicine Department, a PET imaging agent has been developed, Tc-94m sestamibi, and the FDA (Food and Drug Administration) has granted approval for its use in humans.
Objectives:
-To evaluate the feasibility of Tc-94m sestamibi as a PET imaging agent, which should allow greater resolution and quantitation and thereby make possible direct quantitative comparisons of tumor uptake before and after treatment with a P-glycoprotein antagonist.
Eligibility:
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 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PET (positron emission imaging) Imaging with Tc-94m Sestamibi
PET sestamibi scans followed by tariquidar and repeat imaging
干预措施: Tariquidar (Drug)
PET (positron emission imaging) Imaging with Tc-94m Sestamibi
PET sestamibi scans followed by tariquidar and repeat imaging
干预措施: Tc-94m Sestamibi (Drug)
结局指标
主要结局
Percent Change in Tc-94m Sestamibi Body Weight Standardized Uptake Value (SUV) Maximum in Tumor Tissue Before and After Administration of Tariquidar, a P-glycoprotein Antagonist.
时间窗: 3 days
Sestamibi is a Pgp substrate that may be a surrogate for measuring drug efflux from tumors. Significant increase in the SUV in tumor is +25% over baseline.
次要结局
- Number of Participants With Adverse Events(69 months)
研究者
Peter Choyke, M.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)
