AI Algorithms to Automate the TMI by VMAT Optimization Using WB-CT/MRI and Synthetic WB-CT - The AuToMI Project

NCT04976205 | Completed

• 1 other identifier: 2928
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hematological Disease

Outcome Measures

Primary Outcomes (1)

• Reduction of Lymph nodes target volume thanks to WB-MRI

  The PTV\_LN volumes generated on the Simulation WB-MRI and on the Simulation WB-CT will be compared.

  3 years

Secondary Outcomes (1)

• Doses calcuated on CT performed at day -3 (4) to the BMT

  3 years

Study Arms (1)

TMI/TMLI

EXPERIMENTAL

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.

Radiation: Total Marrow (Lymph-node) Irradiation

Interventions

Total Marrow (Lymph-node) Irradiation RADIATION

To the standard procedure for TMI/TMLI target definition, based on simulation WB-CT acquired 10/15 days before BMT, we acquire: WB- magnetic resonance imaging (MRI) the same day of the simulation WB-CT. A verification WB-CT will be performed 3/4 days before the delivery. Plans will be optimized with Volumetric Modulated Arc Therapy (VMAT) technique.

TMI/TMLI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Conditioning regimen including only chemotherapeutic agents

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

IRCCS Humanitas Research Center

Rozzano, Milano, 20089, Italy

Location

Related Publications (1)

• Dei D, Lambri N, Sopranzi C, Galdieri C, Franzese C, Scorsetti M, Mancosu P. Impact of reduced interval from simulation CT to treatment delivery on dosimetric and positioning accuracy for total marrow lymph-node irradiation. Strahlenther Onkol. 2026 Mar;202(3):283-288. doi: 10.1007/s00066-025-02415-x. Epub 2025 Jun 13.

  PMID: 40512423 DERIVED

MeSH Terms

Conditions

Hematologic Diseases

Interventions

Radiation

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 26, 2021
• Study Start: June 15, 2021
• Primary Completion: August 8, 2025
• Study Completion: August 8, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

IT (1)