NCT01759355已完成不适用
Hybrid PET/MR in the Therapy of Cervical Cancer: A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Proportion of patients who successfully complete PET/MR scans at all study time-points
研究概览
简要总结
This is a two arm, single center feasibility study of 20 patients with non-metastatic cervical cancer managed with surgery and/or chemoradiation therapy at UNC Hospitals. Subjects will undergo PET/MRI scans before, during (chemoradiation group only), and after treatment.
详细描述
The primary purpose of this study is to evaluate the feasibility of obtaining complete and interpretable hybrid PET/MR images for patients diagnosed with cervical cancer.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Biopsy-proven, previously untreated squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix
- •Clinically visible lesion at least FIGO stage Ib or AJCC 7th edition T1b
- •Scheduled to undergo standard of care PET/CT for baseline assessment of disease
- •Anticipated to be eligible for curative intent therapy (surgery of chemoradiation therapy) as determined by the patient's primary oncologist
- •If female of child-bearing potential, negative serum or urine pregnancy test ≤ 7 dats prior to first PET/MRI
- •Informed consent reviewed and signed
排除标准
- •History of sever reaction to contrast-enhanced CT scan
- •Inability to tolerate MRI (e.g., inability to lie flat > 1 hour)
- •Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes
- •Poorly controlled diabetes mellitus
- •Creatinine > 1.4 mg/dL or GFR < 30 mL/min
- •Body Mass Index (BMI) > 35
- •Active vaginal bleeding requiring packing and emergent radiation therapy
- •Pregnant or lactating female
- •History of a prior malignancy within past 5 years, unless disease free for ≥ 3 years
- •Substance abuse, medical, psychological, or social conditions that may interfere with study participation
结局指标
主要结局
Proportion of patients who successfully complete PET/MR scans at all study time-points
时间窗: 2-3 months post-treatment
次要结局
- Specificity of hybrid PET/MR for baseline disease assessment(pre-treatment)
- Sensitivity of PET/MR for baseline disease assessment(pre-treatment)
- Accuracy of hybrid PET/MR for baseline disease assessment(pre-treatment)
- Detection of disease with PET/MR at each time point(pre-treatment to 2-3 months post-treatment)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
早期 1 期
PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical CancerStage IA Cervical CancerStage IA1 Cervical CancerStage IA2 Cervical CancerStage IB Cervical CancerStage IB1 Cervical CancerStage IB2 Cervical CancerStage IB3 Cervical CancerNCT04219904M.D. Anderson Cancer Center25
已完成
不适用
A Pilot Study Using Magnetic Resonance (MR) to Assess Cervix Motion During Radiotherapy Treatment.Cervical CancerNCT03101306The Christie NHS Foundation Trust20
Unknown
不适用
Application of Integrated MR-PET in Patients With Gynecologic CancersMR-PET ImagingNCT02292615National Taiwan University Hospital220
招募中
不适用
An Exploratory Study of Using Magnetic Resonance Prognostic Imaging Markers for Radiotherapy In Patients With Cervix Cancer (EMPIRIC Study)Cervical CancerNCT05532930East and North Hertfordshire NHS Trust40
Unknown
不适用
Study on Adaptive Radiotherapy and Multimodal Information of Cervical Cancer Assisted by Artificial IntelligenceRadiotherapy Side EffectBiomarkerArtificial IntelligenceCervical CancerNCT04022018The University of Hong Kong-Shenzhen Hospital122