Automating Total Marrow Irradiation for Hematological Diseases
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
This study is testing a new way to use AI to make Total Marrow Irradiation faster and safer for patients with blood diseases who are getting stem cell transplants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Locations | 1 site (Rozzano, Milano) |
| Trial ID | NCT04976205 on ClinicalTrials.gov |
What this trial studies
This project focuses on optimizing Total Marrow Irradiation (TMI) using advanced AI algorithms to enhance treatment for patients with hematological diseases. The study aims to reduce the time required for TMI planning from 10 days to a more efficient timeframe, thereby improving the overall treatment process for patients undergoing allogeneic stem cell transplantation. By utilizing whole-body CT and MRI imaging, the approach seeks to minimize radiation exposure to healthy tissues while maximizing the therapeutic dose to the bone marrow and lymphatic system. The goal is to improve patient outcomes and reduce toxicities associated with traditional Total Body Irradiation methods.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 and older diagnosed with hematological diseases who are eligible for allogeneic stem cell transplantation.
Not a fit: Patients whose conditioning regimen consists solely of chemotherapeutic agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and reduced side effects for patients undergoing stem cell transplantation.
How similar studies have performed: Preliminary data from phase I/II trials suggest that similar approaches to TMI/TMLI have shown promise in improving outcomes for patients with relapsed-refractory acute leukemia and multiple myeloma.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: - Conditioning regimen including only chemotherapeutic agents
Where this trial is running
Rozzano, Milano
- IRCCS Humanitas Research Center — Rozzano, Milano, Italy (Recruiting)
Study contacts
- Study coordinator: Pietro Mancosu, PhD
- Email: pietro.mancosu@humanitas.it
- Phone: +390282248529
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.