18-fluorofuranylnorprogesterone (FFNP) Positron Emission Tomography-Magnetic Resonance Imaging (PET/MRI) as a Potential Biomarker of Response to Progesterone Therapy in Complex Atypical Hyperplasia (CAH) and Grade 1 Endometrial Cancer (EC)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 8
- 主要终点
- Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MRI for predicting response to progestin therapy in CAH /EC patients
研究概览
简要总结
Purpose: The purpose of this study is to evaluate FFNP PET/MRI's utility for predicting response to Levonorgestrel-releasing Intrauterine Device (LR-IUD) hormonal therapy for Complex Atypical hyperplasia (CAH) and Endometrial Cancer (EC).
Participants: Eight women with histologically confirmed CAH or Grade 1 EC who have planned treatment with LR-IUD will be recruited..
Procedures (methods): The is a prospective, single arm, pilot study of 8 participants who will receive one FFNP PET/MRI scan. Medical records will be followed for 6 months.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female age 18 or older
- •Histologically confirmed CAH or Grade 1 EC
- •No prior surgical or hormonal treatment for CAH or Grade 1 EC
- •Planned treatment with levonorgestrel-releasing intrauterine device (LR-IUD) for CAH or grade 1 EC
排除标准
- •Inability to complete PET/MR scans due to severe claustrophobia
- •Institutionalized subject (prisoner or nursing home subject)
- •Implanted metallic devices, parts, vascular clips, or other foreign bodies.
- •Known hypersensitivity to gadolinium or FFNP or to any component of gadolinium or FFNP refractory to standard medications (antihistamines, steroids)
- •Impaired kidney function (serum creatinine level > 1.8 mg/dl or a glomerular filtration rate < 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
- •Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine (β-HCG) results, obtained within 24 hours before FFNP administration, or on the basis of patient history)
- •Prior hormone treatment for breast cancer
研究组 & 干预措施
18F-fluorofuranylnorprogesterone PET / MRI
All enrolled subjects will receive the tracer and then have a PET/MRI scan.
干预措施: 18F-fluorofuranylnorprogesterone PET / MRI (Drug)
结局指标
主要结局
Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MRI for predicting response to progestin therapy in CAH /EC patients
时间窗: Upon completion of all study image data collection for all participants [approximately 1 year]
The sensitivity of FFNP PET /MR is defined as the ability of readers (radiologists) to correctly detect areas that will respond to treatment, as determined by histopathologic evaluation.
Specificity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MRI for predicting response to progestin therapy in CAH /EC patients
时间窗: Upon completion of all study image data collection for all participants [approximately 1 year]
The specificity is similarly defined as the ability of readers to determine areas that will fail to respond to treatment, as determined by histopathologic evaluation.
次要结局
- Correlate FFNP Maximum Standardized Uptake Value (SUVmax) at baseline and on repeat examination with estrogen and progesterone receptor expression in the CAH/EC tissues at baseline and after 6 months of treatment.(Upon completion of all study image data collection for all participants [approximately 1 year])
- Correlate FFNP Mean Standardized Uptake Value (SUVmean) at baseline and on repeat examination with estrogen and progesterone receptor expression in the CAH/EC tissues at baseline and after 6 months of treatment.(Upon completion of all study image data collection for all participants [approximately 1 year])