Artificial Intelligence Algorithms to Automate the Total Marrow (Lymph-node) Irradiation by VMAT Optimization Using WB-CT/MRI and Synthetic WB-CT - The AuToMI Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction of Lymph nodes target volume thanks to WB-MRI
研究概览
简要总结
Total Body Irradiation (TBI) was shown to help in providing immunosuppression that facilitates the donor transplant acceptance. Randomized trials demonstrated that conditioning regimens to bone marrow transplantation (BMT) including TBI have produced better survival rates than chemo-only regimens. The TBI target is represented by the whole BM, and eventually the whole lymphatic system, liver, spleen. The increased life expectancy revealed the occurrence of important toxicities because of full doses received by organs at risk (OARs) and this limited the use of TBI. Many groups have explored the possibility of sophisticated techniques for reducing the dose to healthy tissues while increasing the dose to the BM. These newer approaches aim to generate total marrow (lymph-node) irradiation (TMI/TMLI), sparing as much as possible non-skeletal and non-lymphoid structures.
Actually, the time required to optimize a TMI/TMLI plan is 10 days. Therefore, the simulation Computed Tomography (CT) is performed many days before the BMT. Furthermore, the lymph-nodes are defined only on CT images.
详细描述
Total Body Irradiation (TBI) was shown to help in providing immunosuppression that facilitates the donor transplant acceptance. Moreover, TBI plays a role in the annihilation of malignant cells, and may also deplete normal hematopoietic stem cells, thus helping the donor marrow cells to repopulate the bone marrow (BM). Randomized trials demonstrated that conditioning regimens to BMT including TBI have produced better survival rates than chemo-only regimens.
The TBI target is represented by the whole BM, and eventually the whole lymphatic system, liver, spleen. Usually, a very simple geometry is adopted, with patient positioned on a dedicated couch at 3-4 meters away from the linear accelerator to fully cover the target with a single beam, avoiding field junctions.
The increased life expectancy revealed the occurrence of important toxicities because of full doses received by organs at risk (OARs) and this limited the use of TBI as stated by the 2018 ILGROG guidelines. Many groups have, therefore, explored the possibility of sophisticated techniques for reducing the dose to healthy tissues while increasing the dose to the BM. These newer approaches aim to generate total marrow (lymph-node) irradiation (TMI/TMLI), sparing as much as possible non-skeletal and non-lymphoid structures.
Preliminary clinical data on phase I/II trials support the use of TMI/TMLI as part of conditioning for BMT for relapsed-refractory acute leukemia patients and multiple myeloma. However, TMI/TMLI adoption is still very limited to few skilled hospitals due to the extreme difficulty in the planning that needs many days.
The evaluation of TMI/TMLI with Volumetric Modulated Arc Therapy (VMAT) was started in our institute in 2009 and we treated around 90 patients in 10 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written, signed informed consent
- •Adult patients aged ≥18 years
- •Diagnosis of Hematological disease
- •Eligibility for allogeneic stem cell transplantation as center guidelines
- •TMI/TLI as part of the conditioning regimen
排除标准
- •Conditioning regimen including only chemotherapeutic agents
研究组 & 干预措施
TMI/TMLI
The standard planning optimization for TMI/TMLI preview a two-free-breathing-CT scan without contrast will be performed for simulation at day -15(-10) to the BMT. The same day a WB-MRI will be acquired for lymph-nodes delineation. WB-MRI scans will be performed using a 1.5T MR scanner. The two CT will be co-registered to the WB-MRI.
CTV will be manually defined as the bones excluding mandible and hands (CTVBones), the spleen (CTVSpleen), and lymph nodes (CTVLN) using both MRI and CT images. The day -3 (4) to the BMT, further two-CT series will be acquired and co-registered to the first CTs for dose verification. Pre-treatment quality assurance (QA) will be performed the day before the treatment using the standard internal procedure.
The treatment will be performed the day before the BMT.
干预措施: Total Marrow (Lymph-node) Irradiation (Radiation)
结局指标
主要结局
Reduction of Lymph nodes target volume thanks to WB-MRI
时间窗: 3 years
The PTV_LN volumes generated on the Simulation WB-MRI and on the Simulation WB-CT will be compared.
次要结局
- Doses calcuated on CT performed at day -3 (4) to the BMT(3 years)