MRI Guided Brachytherapy for HPV-Associated Cervical and Vaginal Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Percent of patients achieving high-risk clinical target volume (HR-CTV) dose to 90% (D90)
研究概览
简要总结
This trial studies how well magnetic resonance imaging (MRI)-guided internal radiation therapy (brachytherapy) works in treating participants with human papillomavirus (HPV) associated stage IB2-IV cervical or stage II-IVA vaginal cancer. Using MRI guidance during brachytherapy applicator placement may improve treatment planning in participants with cervical or vaginal cancer.
详细描述
PRIMARY OBJECTIVES:
I. Determine whether MRI guidance during internal radiation therapy applicator placement improves the high-risk clinical target volume (HR-CTV) D90 (dose to 90% of the high-risk clinical target volume) rate compared to conventional guidance, with ultrasound and freehand technique, for patients with cervical and vaginal cancer.
SECONDARY OBJECTIVES:
I. Identify diffusion weighted MRI image features that can be used to identify sites of viable tumor following external beam radiotherapy as assessed by tumor aspirate cytology.
II. Determine if diffusion weighted MRI findings are associated with immune infiltration as assessed by multi-spectral flow cytometry.
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
- •Women with stage 1B2-IVA cervical cancer recommended to receive definitive chemoradiation including brachytherapy; or
- •Women with stage II-IVA vaginal cancer recommended to receive definitive chemoradiation including brachytherapy.
排除标准
- •Patient or tumor anatomy that requires use of a non-MRI-compatible applicator.
- •Patients with implantable cardioverter-defibrillator, pacemaker or other implanted device or medical condition which precludes MRI acquisition.
研究组 & 干预措施
Treatment (MRI, internal radiation therapy)
Participants undergo MRI scan during internal radiation therapy applicator placement.
干预措施: Magnetic Resonance Imaging (Procedure)
Treatment (MRI, internal radiation therapy)
Participants undergo MRI scan during internal radiation therapy applicator placement.
干预措施: Internal Radiation Therapy (Radiation)
结局指标
主要结局
Percent of patients achieving high-risk clinical target volume (HR-CTV) dose to 90% (D90)
时间窗: Up to 4 years
Rate will be compared to conventional guidance, with ultrasound and freehand technique. We will compare the HR-CTV D90 and other secondary dosimetry parameters (e.g. D2 cc bladder, D2 cc rectum etc.) between the initial scan (subsequent to ultrasound \[US\] guided or freehand applicator placement) and optimized (with magnetic resonance imaging \[MRI\] guided placement) treatment plan for each patient using McNemar's test.
次要结局
- Diffusion weighted imaging (DWI) outcomes(Up to 4 years)
- Progression-free survival(Up to 4 years)
- Biomarker measurements (tumor viability and tumor T cell profile) from tumor samples(Up to 4 years)
- Overall survival(Up to 4 years)
- Disease recurrence (local, regional, and distant)(Up to 4 years)
- Cost difference associated with the MRI-guided versus the standard process(Up to 4 years)
- Incidence and severity of treatment-related toxicities(Up to 4 years)