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FLASH Pilot Phase 1 Safety Study

2026年5月20日 更新者:Lesley A. Jarvis

A Pilot Study to Determine the Feasibility of Electron FLASH Radiotherapy for Treatment of De-novo Cutaneous Lymphoma

The primary purpose of this research trial is to study the safety of electron FLASH treatment for cutaneous lymphoma lesions. In addition, investigators will confirm the accuracy of dose and dose rate delivery of electron FLASH therapy using on-patient dosimetry measurements in combination with FAST camera imaging. Researchers will also determine the response rates of cutaneous lymphomas treated with a low radiation dose in a single fraction using electron UHDR treatments, followed by an assessment of radiation related skin toxicity.

研究概览

研究类型

介入性

注册 (估计的)

10

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。

学习联系方式

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Histologic proof of cutaneous lymphoma.
  2. The cutaneous lymphoma is not planned to be treated with definitive, higher dose radiotherapy therapy.
  3. Participant is planned to receive a course of palliative radiation therapy at DHMC for a cutaneous lymphomas lesion located on an extremity (see appendix A) that can be encompassed in a field size no larger than 7.5 cm in diameter.
  4. No prior history of radiotherapy to the site of planned treatment.
  5. Patient agrees to discontinue topical therapy, including steroid creams or chemotherapy agents, to the index lesion 4 weeks prior to the radiation treatment.
  6. Participant must be capable of providing informed consent or has an acceptable surrogate capable of providing consent on behalf of the participant.
  7. Adults at least 18 years of age
  8. Eastern Cooperative Oncology Group performance status of <3.
  9. Women of childbearing potential (WOCBP): Premenopausal females who had at least one menstrual cycle in the past 12-months and capable to become pregnant, must have a negative serum beta-HCG pregnancy test result within seven days prior to start of treatment.
  10. WOCBP who are sexually active must agree at study entry to use adequate methods of contraception during treatment.

Exclusion Criteria:

  1. Prior radiotherapy to the site of treatment.
  2. Index lesion UHDR treatment field is <5cm from the field edge of a synchronously treated CONV lesion.
  3. Patient receiving prescribed hormonal therapies.
  4. Patients with known NCI CTCAE V5.0 grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection.
  5. Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol.
  6. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent process.

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:设备可行性
  • 分配:非随机化
  • 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:Experimental arm treated with FLASH Radiation Therapy
In participants with more than one cutaneous lesion requiring treatment, one lesion will be treated with electron FLASH therapy. The prescription dose will be 8 Gray (Gy) in 1 fraction.

The Mobetron UDHR System provides electrons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

The FLASH enabled Mobetron System is intended to deliver electron FLASH radiotherapy to participants with cutaneous lymphoma lesions located in extremities.

有源比较器:Control arm treated with Conventional Radiation Therapy
In participants who have more than one cutaneous lesion requiring treatment, the remainder of the lesions not treated with electron FLASH therapy will be treated with conventional electron treatment at the discretion of the treating radiation oncologist.
Conventional radiotherapy

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
Safety and toxicity profile characterization of electron FLASH treatment
大体时间:5 years
To study the safety and characterize the toxicity profile of electron FLASH treatment, a clinical evaluation of all lesions treated will be performed on all grade 3 or higher toxicities according to the Common Terminology Criteria for Adverse Effects (CTCAE) version 6.0.
5 years

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。

合作者

调查人员

  • 首席研究员:Lesley A Jarvis, MD、Dartmouth-Hitchcock Medical Center

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 (估计的)

2029年10月31日

初级完成 (估计的)

2030年12月31日

研究完成 (估计的)

2031年12月31日

研究注册日期

首次提交

2026年5月20日

首先提交符合 QC 标准的

2026年5月20日

首次发布 (实际的)

2026年5月27日

研究记录更新

最后更新发布 (实际的)

2026年5月27日

上次提交的符合 QC 标准的更新

2026年5月20日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

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

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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