A Pilot Study of FLT-PET/MRI for Early Response Monitoring to Novel Cancer Therapeutic Agents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Concordance analysis of standardized uptake values (SUVs) between the 2 baseline scans
研究概览
简要总结
This pilot clinical trial studies fluorine F 18 fluorothymidine (FLT)-positron emission tomography/magnetic resonance imaging (PET/MRI) in measuring early response in patients with metastatic solid tumors receiving treatment that blocks blood flow to the tumor. Diagnostic procedures, such as FLT-PET/MRI, may help measure a patient's response earlier during treatment.
详细描述
PRIMARY OBJECTIVES:
The primary objective of this pilot imaging study is to determine the feasibility of FLTPET/MR imaging for early prediction of treatment response in patients undergoing antiangiogenic cancer treatment. The study will assess PET/MRI test-retest reproducibility and compare baseline PET/MRI with PET/MRI after initiation (within 2-4 weeks) of antiangiogenic therapy.
SECONDARY OBJECTIVES:
- To compare early changes in PET biomarker (FLT) tumor uptake with treatment response assessed at completion of therapy (prediction of treatment response).
- To compare changes in MRI signal intensities (multi-parametric MRI) with treatment response assessed at completion of therapy.
- To compare results from multi-parametric MR imaging with FLT tumor uptake.
- To assess combinations of quantitative PET and MRI metrics.
OUTLINE:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 with metastatic solid tumors scheduled to undergo treatment with novel cancer therapeutic agents as standard of care (SOC) treatment.
- •Patients able to tolerate PET/MRI scans
- •Informed consent must be given and signed
排除标准
- •Subjects who do not meet the above mentioned inclusion criteria
- •Subjects who refuse to give and/or sign the informed consent
- •Patients who currently have a pacemaker
- •Patients who have a history of serious adverse events related to a previous MRI or PET/CT
- •Patients who are unable to undergo MRI scanning due to exclusion by UHCMC MRI restriction policies as mentioned in the standard UHCMC MRI informed consent form
- •Patients with a known allergy against any component of the contrast enhancing agent
- •Patients who currently pregnant or breast feeding; negative serum pregnancy test within 72 hours of their first FLT-PET/MRI
- •Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 4 weeks
- •Renal insufficiency: elevated creatinine and/or glomerular filtration rate (GFR) < 40 ml/min/1.73^2 (exclusion criterion only for contrast enhanced MRI)
结局指标
主要结局
Concordance analysis of standardized uptake values (SUVs) between the 2 baseline scans
时间窗: Baseline
A sample size of 20 produces a two-sided 95% confidence interval \[0.553, 0.918\] for the Pearson correlation coefficient when the sample correlation is 0.80. Additional analysis for concordance will include Bland-Altman plots and intraclass correlation.
Comparative Analysis of PET/MRI Images
时间窗: Up to 4 weeks
Describe changes in images at baseline PET/MRI scan compared to PET/MRI image taken after initiation of anti-angiogenic therapy
次要结局
未报告次要终点