PET/MR in Assessing Response to Neoadjuvant Radiation Therapy in the Tx of High Grade Sarcomas
2021年3月2日 更新者：UNC Lineberger Comprehensive Cancer Center
Utility of PET/MR in Assessing Response to Neoadjuvant Radiation Therapy in the Treatment of High Grade Sarcomas
Purpose: To assess the utility of PET/MR in assessing response to neoadjuvant radiation therapy in the treatment of high grade sarcomas.
Participants: Adult patients with potentially curable high grade sarcomas that are being treated at UNC with neoadjuvant radiation therapy followed by potentially curative surgical resection.
Procedures (methods): Patients who are being treated for potentially curable high grade sarcomas with neoadjuvant radiation therapy followed by surgical resection undergo pre-treatment, mid-treatment, and post-treatment PET/MR and the response to treatment is assessed by evaluating change in size and FDG avidity. Patients then undergo curative intent resection and are followed. Their pathology is reviewed for treatment affect as is assessed by percent necrosis, size, and resection margins. Patients are followed and assessed for recurrence.
研究概览
详细说明
Investigators propose that a PET/MR study at the midpoint of radiation treatment will accurately predict which patients will respond to neoadjuvant radiation therapy.
The study will enroll patients with high-grade sarcomas as identified by preoperative biopsy that will be treated with neoadjuvant radiation into the study.
The standard of care for these patients is to receive MRI scans at pre-treatment and post-treatment time points.
Patients in this study will receive their standard pre- and post-treatment imaging in the form of PET/MR, with PET conducted simultaneously with MRI, and within the context of the study they will also receive one additional PET/MR at the end of the second week of therapy.
These patients will then receive curative intent surgery and be followed in the usual fashion and assessed for local and/or distant recurrent disease.
The pathology will be assessed for completeness of resection and percent of necrosis.
On the basis of pathology, patients will be classified as responsive or non-responsive to therapy.
Quantitative measures from PET and MRI will be computed: the change in PET tumor-mean standardized uptake value (SUV) and tumor size as assessed by MRI, from pre- to post-treatment, and from pre- to mid-treatment.
The image-based quantitative measures will be correlated with the pathology outcomes to evaluate predictability of the image measures for treatment response.
Patients will be followed with the intent of further correlating image measures with clinical outcomes.
研究类型
介入性
注册 (实际的)
3
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
North Carolina
-
Chapel Hill、North Carolina、美国、27599
- UNC-Chapel Hill
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 99年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age ≥ 18 years of age (no upper age limit)
- Signed, IRB-approved written informed consent
- Must have a biopsy-proven high-grade retroperitoneal or soft tissue extremity sarcoma confirmed by independent evaluation of a UNC sarcoma specialized pathologist.
- Must have surgically curable disease as evaluated by initial imaging by our UNC surgeons.
- Must be in acceptable health to undergo radiation therapy and curative intent surgery as assessed by UNC surgeons and radiation oncologist.
- Must be able to understand and comply with study procedures for the entire length of the study.
- Must receive their neoadjuvant radiation therapy and curative intent surgery at UNC Hospitals - Chapel Hill location.
- Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to each PET/MRI
Exclusion Criteria:
- Inability to tolerate MRI (e.g., inability to lie flat for >1 hour)
- Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes or near pelvis that would create excessive imaging artifact
- Poorly controlled diabetes mellitus
- Creatinine > 1.8 mg/dL OR GFR < 30mL/min
- Body Mass Index (BMI) > 35
- Active vaginal bleeding requiring packing and emergent radiation therapy
- Pregnancy or lactating female
- History of a prior malignancy within past 5 years are excluded unless they have been disease free for 3 or more years
- Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study
- Evidence of distant disease on physical exam or initial imaging
- Medical conditions precluding radiation therapy or curative intent surgery
- Previous radiation exposure precluding radiation therapy
- Had serious reaction to contrast agent
- Incarcerated or otherwise institutionalized at time of enrollment
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Single Arm: PET/MR
Each patient will undergo three combined PET/MR scans.
The pre-treatment PET, mid-treatment PET and MR, and post-treatment PET are for research purposes and not part of the patient's standard of care (pre-treatment MR and post-treatment MR).
|
Patient will be scheduled for a pre-treatment PET/MR and proceed to neoadjuvant radiation therapy per the direction of the radiation oncologist.
At the end of the second week of radiation therapy the patient will undergo a mid-treatment PET/MR.
The patient will the complete their radiation therapy.
Four weeks after radiation therapy the patient will undergo a post-treatment PET/MR, and proceed for curative intent surgery at 6-8 weeks post radiation if they are still surgical candidates.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
PET Activity Estimates at Midpoint of Treatment as Compared to Baseline
大体时间：At the end of the second week of radiation therapy, a mid-treatment PET/MR is obtained.
|
Primary endpoint is the determination of differences among response groups in PET activity estimates from PET/MR imaging at the midpoint of treatment as compared to baseline.
The measure is computed as the change in mean SUV from the baseline PET-MR scan to the scan at the end of the second week of therapy.
Treatment response will be determined on final pathological evaluation of the resected specimens in patients who undergo curative intent surgery after neoadjuvant radiation in high grade sarcomas.
This will be measured by a single sarcoma specialized pathologist and will be categorized as to the percentage of necrosis, with >90% necrosis considered to be complete response.
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At the end of the second week of radiation therapy, a mid-treatment PET/MR is obtained.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
PET Activity Estimates at Endpoint of Treatment as Compared to Baseline
大体时间：A post-treatment PET/MR is obtained at 4 weeks post radiation.
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A secondary endpoint is the determination of differences among response groups in PET activity estimates from PET/MR imaging at the endpoint of treatment as compared to baseline.
The measure is computed as the change in mean SUV from the baseline PET-MR scan to the scan taken four weeks after completion of therapy.
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A post-treatment PET/MR is obtained at 4 weeks post radiation.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：David Lalush, PhD、UNC Biomedical Engineering
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年4月1日
初级完成 (实际的)
2019年12月30日
研究完成 (实际的)
2020年1月31日
研究注册日期
首次提交
2017年3月6日
首先提交符合 QC 标准的
2017年3月6日
首次发布 (实际的)
2017年3月10日
研究记录更新
最后更新发布 (实际的)
2021年3月26日
上次提交的符合 QC 标准的更新
2021年3月2日
最后验证
2021年1月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- LCCC 1615
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
是的
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