The Value of Advanced MR Imaging in Gynecological Tumors and Benign Uterine Fibroids
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Number of Patients With Feasible Imaging
研究概览
简要总结
This research is being done to test new MRI methods called Magnetic Resonance Fingerprinting and Q-space Trajectory Imaging in gynecological abnormalities. The purpose of this research study is to evaluate if these new MRI methods can give additional information in characterizing gynecological tumors compared with conventional MRI.
详细描述
Magnetic resonance imaging (MRI) is a safe and painless test that uses a magnetic field and radio waves to produce detailed images of the body's organs and structures. This research is being done to test new MRI methods called Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) in gynecological abnormalities. The purpose of this research study is to evaluate if these new MRI methods can give additional information in characterizing gynecological tumors compared with conventional MRI
In this research study, the investigators are:
- Investigating the use of MR imaging in gynecological tumors on imaging quality and comparison of tumor or fibroid structures and normal anatomy
- Investigating whether new MRI methods could help in characterizing the tumor and give information about the expected outcome
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
- 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
- •Participants with suspected or histologically confirmed diagnosis of primary or recurrent gynecological cancer including uterine endometrial, cervical, vaginal, vulvar, ovarian, and smooth-muscle tumors undergoing routine clinical standard of care pelvic MRI
- •Control subjects with benign fibroids undergoing routine clinical standard of care pelvic MRI
- •Age ≥ 18 years
- •ECOG performance status of ≤ 2, based on treating physician's discretion (Appendix A)
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Contraindication to MRI identified by the MR procedure screening form, such as a pacemaker, aneurysm clip, inner ear implant, neurostimulator, or other MR non-compatible device or implant
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Adults unable to consent
- •Non-english speaking subjects
- •Pregnant women
- •Prisoners
研究组 & 干预措施
GYN Benign Controls
- Benign gynecological (GYN) fibroids.
- Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years.
干预措施: Magnetic Resonance Imaging Machine (MRI) (Device)
GYN Cancer Cases
- Confirmed diagnosis of primary or recurrent gynecological (GYN) malignancies.
- Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years.
干预措施: Magnetic Resonance Fingerprinting (MRF) (Device)
GYN Cancer Cases
- Confirmed diagnosis of primary or recurrent gynecological (GYN) malignancies.
- Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years.
干预措施: Q-space Trajectory Imaging (QTI) (Device)
GYN Cancer Cases
- Confirmed diagnosis of primary or recurrent gynecological (GYN) malignancies.
- Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years.
干预措施: Magnetic Resonance Imaging Machine (MRI) (Device)
GYN Benign Controls
- Benign gynecological (GYN) fibroids.
- Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years.
干预措施: Magnetic Resonance Fingerprinting (MRF) (Device)
GYN Benign Controls
- Benign gynecological (GYN) fibroids.
- Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years.
干预措施: Q-space Trajectory Imaging (QTI) (Device)
结局指标
主要结局
Number of Patients With Feasible Imaging
时间窗: Day 1
Feasibility is determined by both A) having evaluable images in terms of quality according to radiology review and B) having a complete set of tumor metrics \[MRF (T1 and T2 relaxation values) and QTI (total mean kurtosis MKT, microscopic anisotropy MKA, isotropic heterogeneity MK1, fractional anisotropy FA, microscopic fractional anisotropy µFA)\]
次要结局
- MRF T1 Relaxation Value(Day 1)
- MRF T2 Relaxation Value(Day 1)
- QTI Isotropic Heterogeneity MK1(Day 1)
- QTI Microscopic Fractional Anisotropy µFA(Day 1)
- QTI Total Mean Kurtosis(Day 1)
- QTI Fractional Anisotropy FA(Day 1)
- QTI Microscopic Anisotropy MKA(Day 1)
- Median Overall Survival(Up to 4 years)
研究者
Clare Tempany
Principal Investigator
Dana-Farber Cancer Institute