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| Name | Class |
|---|---|
| Dartmouth College | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm treated with FLASH Radiation Therapy | Experimental | 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. |
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| Control arm treated with Conventional Radiation Therapy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IntraOp Mobetron UHDR | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and toxicity profile characterization of electron FLASH treatment | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lesley A Jarvis, MD | Contact | 603-650-6600 | lesley.a.jarvis@hitchcock.org |
| Name | Affiliation | Role |
|---|---|---|
| Lesley A Jarvis, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D010315 | Particle Accelerators |
| ID | Term |
|---|---|
| D055618 | Radiation Equipment and Supplies |
| D004864 | Equipment and Supplies |
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This is a prospective, single institution safety study of electron FLASH radiation treatment (RT) for participants with cutaneous lymphomas. The primary study objective is to determine the safety and characterize the toxicity profile of electron FLASH treatment to participants receiving palliative radiotherapy for cutaneous lymphomas.
A maximum of 10 participants will be enrolled. Participants with more than one cutaneous lesion requiring treatment will have one lesion treated with electron FLASH therapy. The remainder of the lesions will be treated with conventional electron treatment, allowing such participants to serve as their own internal control.
The duration of an individual participant's time in the study will include the simulation and treatment planning duration (<4 weeks). Participants will be clinically assessed for 5 years after completion of the radiation treatment.
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| Linac | Radiation | Conventional radiotherapy |
|
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |