Detection of Integrin Alpha-v-Beta 6 in Pancreatic Cancer With [18F]-R01-MG-F2: a First in Human Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Dosimetry of [18F]FP-R01-MG-F2 (rem/mCi)
研究概览
简要总结
This pilot clinical trial studies the use of integrin alpha-v-beta [18F]-R01-MG-F2 Positron Emission Tomography/Computed Tomography (PET/CT) and Positron Emission Tomography-Magnetic Resonance Imaging in (PET/MRI) in measuring response in patients with pancreatic cancer and healthy volunteers. Integrins, such as integrin alpha-v-beta-6 (avb6), are a family of membrane receptors that are overexpressed on the cell surface of pancreatic cancers. [18F]-R01-MG-F2 targets avb6, which may improve early detection of and better stratify treatment options for patients with pancreatic cancer.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the biodistribution and safety of [18F]FP-R01-MG-F2 in healthy volunteers.
II. Evaluate the feasibility of [18F]FP-R01-MG-F2 PET/CT scanning in patients with pancreatic cancer.
OUTLINE:
Patients receive [18F]FP-R01-MG-F2 intravenously (IV) and undergo PET/CT or PET/MR scan immediately after and at 60 and 120 minutes. Patients will be followed up at 24-48 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Healthy volunteers:
- •Must be 18 years of age or older.
- •Must have no known medical problems and have had a full medical exam within 6 months of the study. If healthy volunteers have not had a full medical exam within 6 months of the study, one of the nuclear medicine physicians will conduct the medical exam prior to any study procedures.
- •Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained.
- •Women of child bearing potential (as defined as women who are not post menopausal for 12 months or who have had no previous surgical sterilization) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 30 days after the last dose.
- •Pancreatic cancer subjects:
- •Participant must be 18 years or older at the time of radiotracer administration
- •Provides written informed consent
- •Suspected or established diagnosis of pancreatic cancer based on any radiographic scan or pathology and who is scheduled for surgery OR Biopsy proven diagnosis of pancreatic cancer who is no longer a surgical candidate
排除标准
- •Healthy volunteers:
- •Participant is less than 18 year-old
- •Pregnant or breast feeding women.
- •Patients who are not likely to comply with the protocol requirements.
- •Pancreatic cancer subjects:
- •Participant is pregnant or breast-feeding
- •Participant is not able to comply with the study procedures
- •Participant has serious uncontrolled concurrent medical illness that would limit compliance with study requirements
- •Metallic implants (contraindicated for MRI)
- •History of renal insufficiency (only for MRI contrast administration)
研究组 & 干预措施
healthy patients
Patients receive [18F]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.
干预措施: Laboratory Biomarker Analysis (Other)
pancreatic cancer patients
Patients receive [18F]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.
干预措施: Computed Tomography (Diagnostic Test)
pancreatic cancer patients
Patients receive [18F]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.
干预措施: Laboratory Biomarker Analysis (Other)
pancreatic cancer patients
Patients receive [18F]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.
干预措施: PET/MRI scan (Diagnostic Test)
pancreatic cancer patients
Patients receive [18F]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.
干预措施: [18F]FP-R01-MG-F2 (Drug)
healthy patients
Patients receive [18F]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.
干预措施: Computed Tomography (Diagnostic Test)
healthy patients
Patients receive [18F]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.
干预措施: PET/MRI scan (Diagnostic Test)
healthy patients
Patients receive [18F]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.
干预措施: [18F]FP-R01-MG-F2 (Drug)
结局指标
主要结局
Dosimetry of [18F]FP-R01-MG-F2 (rem/mCi)
时间窗: Up to 3 hours after tracer injection
Using the biodistribution data (uptake in %ID/g or SUV), the tracer's complete dosimetry across all organs, tissues or cells will be determined using the OLINDA software. These data will be reported in rem/mCi.
Biodistribution of [18F]FP-R01-MG-F2 (%ID/g)
时间窗: Up to 3 hours after tracer injection
From the Region-of-Interest (ROI) image analysis, the biodistribution data will be reported in percent injected dose per gram of tissue (%ID/g). ROI analysis will be performed on normal brain, thyroid, lungs, mediastinum, liver, spleen, intestines, kidneys, urinary bladder and gluteal muscle.
Biodistribution of [18F]FP-R01-MG-F2 (SUV)
时间窗: Up to 3 hours after tracer injection
From the Region-of-Interest (ROI) image analysis, the biodistribution data will be reported in Standardized Uptake Values (SUV). ROI analysis will be performed on normal brain, thyroid, lungs, mediastinum, liver, spleen, intestines, kidneys, urinary bladder and gluteal muscle.
Dosimetry of [18F]FP-R01-MG-F2 (mSv/MBq)
时间窗: Up to 3 hours after tracer injection
Using the biodistribution data (uptake in %ID/g or SUV), the tracer's complete dosimetry across all organs, tissues or cells will be determined using the OLINDA software. These data will be reported in mSv/MBq.
次要结局
未报告次要终点