Clinical Feasibility and Potential Clinical Benefit of 68Ga-DOTATATE PET/CT Assessment of Soft Tissue Sarcomas for Potential Peptide Receptor Radionuclide Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Regions of pathologically increased tracer uptake
研究概览
简要总结
This trial studies how well 68Ga-DOTATATE digital PET/CT work in diagnosing soft tissue sarcoma. 68Ga-DOTATATE is a radiotracer that may improve image quality of PET imaging. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 68Ga-DOTATATE. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. 68Ga-DOTATATE digital PET/CT may work better in imaging patients with soft tissue sarcomas.
详细描述
PRIMARY OBJECTIVE:
I. To assess the feasibility and capability of gallium Ga 68-HA-DOTA-TATE (68Ga-DOTATATE) digital positron emission tomography (dPET)/ computed tomography (CT) imaging for soft tissue sarcomas.
SECONDARY OBJECTIVES:
I. To evaluate the clinical benefit of 68Ga-DOTATATE for a comprehensive assessment of soft tissue sarcomas (STS) using next-generation digital PET detector technology.
II. To describe the perfusion and early tumor uptake kinetics of tumor targets at baseline and following conventional systemic therapy using both 68Ga-DOT AT A TE dPET/CT and 18F-FDG dPET/CT approaches.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >= 18 years of age
- •Patients diagnosed with any stage of soft tissue sarcomas candidates for systemic therapies
- •Patients with one standard of care PET/CT scan up to 30 days before enrollment at the Ohio State University facilities.
排除标准
- •Hypersensitivity to somatostatin or similar peptides
- •Somatostatin long-acting analog in the past 6 months
- •Patients who are pregnant or lactating
- •Patients who are currently incarcerated
- •Patients with acute infections
- •Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- •Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the dPET/CT scanner due to body mass index (BMI)
研究组 & 干预措施
Diagnostic (68Ga-DOTATATE dPET/CT)
Patients receive gallium Ga 68-HA-DOTA-TATE intravenously (IV) and undergo dPET/CT over 60 minutes up to two weeks after starting standard chemotherapy. Beginning 24 hours after gallium Ga 68-HA-DOTA-TATE dPET/CT, patients also receive fludeoxyglucose F-18 IV and undergo dPET/CT over 60 minutes..
干预措施: Computed Tomography (Procedure)
Diagnostic (68Ga-DOTATATE dPET/CT)
Patients receive gallium Ga 68-HA-DOTA-TATE intravenously (IV) and undergo dPET/CT over 60 minutes up to two weeks after starting standard chemotherapy. Beginning 24 hours after gallium Ga 68-HA-DOTA-TATE dPET/CT, patients also receive fludeoxyglucose F-18 IV and undergo dPET/CT over 60 minutes..
干预措施: Gallium Ga 68-HA-DOTA-TATE (Radiation)
Diagnostic (68Ga-DOTATATE dPET/CT)
Patients receive gallium Ga 68-HA-DOTA-TATE intravenously (IV) and undergo dPET/CT over 60 minutes up to two weeks after starting standard chemotherapy. Beginning 24 hours after gallium Ga 68-HA-DOTA-TATE dPET/CT, patients also receive fludeoxyglucose F-18 IV and undergo dPET/CT over 60 minutes..
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Regions of pathologically increased tracer uptake
时间窗: At completion of imaging
Positron emission tomography (PET) images will be evaluated visually for regions of pathologically increased tracer uptake that could not be attributed to normal physiologic activity. The non-contrast enhanced computed tomography images are used for attenuation correction and for fusion with PET images to allow for anatomical - localization of PET findings.
次要结局
- Incidence of adverse events(Up to 7 days after completion of imaging)
研究者
Gabriel Tinoco
Principal Investigator
Ohio State University Comprehensive Cancer Center