Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CT
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Poly (ADP-ribose) polymerase inhibitor (PARP)-1 activity as assessed by fluorine F 18 fluorthanatrace positron emission tomography/computed tomography
研究概览
简要总结
This phase I trial studies how well fluorine F 18 fluorthanatrace positron emission tomography (PET)/computed tomography (CT) works in patients with solid tumors. Fluorine F 18 fluorthanatrace is a radioactive tracer, a type of imaging agent that is labeled with a radioactive tag and injected into the body to help with imaging scans. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the body. PET/CT with Fluorine F 18 fluorthanatrace may allow more tumor cells to be found in patients with ovarian, fallopian tube, or primary peritoneal cancer.
详细描述
PRIMARY OBJECTIVES:
- Evaluate fluorine F 18 fluorthanatrace ([18F]Fluorthanatrace) positron emission tomography/computed tomography (PET/CT) as an imaging biomarker of poly [ADP-ribose] polymerase (PARP)-1 activity in 3 cohorts of cancer patients: 1) ovarian, fallopian tube, primary peritoneal 2) breast cancer, and 3) non-ovarian, non-breast solid tumor.
SECONDARY OBJECTIVES:
- Evaluate the safety of [18F]Fluorthanatrace.
- Correlate [18F]Fluorthanatrace uptake measures with BRCA mutation status.
- Correlate [18F]Fluorthanatrace uptake measures with poly [ADP-ribose] polymerase (PARP-1) activity in tumor tissue samples in patients who undergo biopsies.
- Evaluate change in [18F]Fluorthanatrace uptake measures after therapy initiation with repeat imaging before and after treatment initiation.
- To confirm the variability of imaging findings from repeated [18F]FTT PET/CT over 1 week before treatment initiation
- Determine the change in [18F]FluorThanatrace uptake before treatment initiation and at time of clinical progression
- Correlate [18F]FluorThanatrace uptake at time of clinical progression measures with genetic reversion mutation status
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •History of known or suspected solid tumor.
- •At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. computed tomography [CT], magnetic resonance imaging [MRI], ultrasound, fludeoxyglucose [FDG] PET/CT).
排除标准
- •Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential < 2 weeks prior to screening as standard of care.
- •Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
- •Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.
研究组 & 干预措施
Treatment (FDG PET/CT, [18F]FTT PET/CT)
Patients receive FDG IV and undergo FDG PET/CT scan over 20-30 minutes if they have not already had one per standard of care. At least 20-24 hours later, patients receive fluorine F 18 fluorthanatrace IV and undergo [18F]FTT PET/CT over 1 hour.
干预措施: Computed Tomography (Procedure)
Treatment (FDG PET/CT, [18F]FTT PET/CT)
Patients receive FDG IV and undergo FDG PET/CT scan over 20-30 minutes if they have not already had one per standard of care. At least 20-24 hours later, patients receive fluorine F 18 fluorthanatrace IV and undergo [18F]FTT PET/CT over 1 hour.
干预措施: Fluorine F 18 Fluorthanatrace (Radiation)
Treatment (FDG PET/CT, [18F]FTT PET/CT)
Patients receive FDG IV and undergo FDG PET/CT scan over 20-30 minutes if they have not already had one per standard of care. At least 20-24 hours later, patients receive fluorine F 18 fluorthanatrace IV and undergo [18F]FTT PET/CT over 1 hour.
干预措施: Positron Emission Tomography (Procedure)
Treatment (FDG PET/CT, [18F]FTT PET/CT)
Patients receive FDG IV and undergo FDG PET/CT scan over 20-30 minutes if they have not already had one per standard of care. At least 20-24 hours later, patients receive fluorine F 18 fluorthanatrace IV and undergo [18F]FTT PET/CT over 1 hour.
干预措施: Fludeoxyglucose F-18 (Radiation)
结局指标
主要结局
Poly (ADP-ribose) polymerase inhibitor (PARP)-1 activity as assessed by fluorine F 18 fluorthanatrace positron emission tomography/computed tomography
时间窗: Up to 4 years
Data will be generated for semi-parametric uptake of both tracers by patient and by lesion as well as by PARP activity, and summarized as mean and standard deviation (SD) across patients. For patients for whom tumor tissue is saved, the correlation of uptake values and PARP activity as assayed from biopsy specimens will be measured using the rank correlation (Spearman's rho), and test for significance compared to no correlation.
次要结局
- Change in fluorine F 18 fluorthanatrace uptake measures after therapy(Baseline up to 4 years)
- Incidence of adverse events(Up to 4 years)
- BRCA mutation status(Up to 4 years)
- PARP-1 activity in tumor tissue samples(Up to 4 years)