Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Liver Metastases
Official title: Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases - MAESTRO -
Run by University Hospital Heidelberg · NCT05027711 · Data updated 2026-11-12
This study is testing a new type of radiation therapy for patients with liver cancer that uses real-time imaging to see if it can target tumors better and protect healthy tissue compared to standard methods.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | University Hospital Heidelberg Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Heidelberg) |
| Status | Recruiting |
| Started | August 12, 2021 |
| Main results expected | January 31, 2029 |
| Study ends | January 31, 2030 |
| Registry record updated | March 10, 2026 |
| Trial ID | NCT05027711 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with 1-3 hepatic metastases from solid tumors, each measuring 5 cm or less.
✕Probably not a fit
Patients with primary liver cancer, those who have undergone liver transplantation, or those with significant liver function impairment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of Magnetic Resonance-guided Stereotactic Body Radiotherapy (MRgSBRT) compared to traditional Internal Target Volume-based Stereotactic Body Radiotherapy (ITV-SBRT) for patients with hepatic metastases. The study aims to improve treatment precision by utilizing real-time imaging and adaptive techniques to minimize radiation exposure to surrounding healthy tissues. It involves a prospective, randomized design with 82 participants who have 1-3 hepatic metastases. The trial will assess safety, efficacy, and potential dose escalation benefits of MRgSBRT.
Why it matters
Potential benefit: If successful, this approach could lead to improved local control of liver metastases with reduced treatment-related toxicity.
How similar studies have gone: While there are limited retrospective analyses on MR-guided SBRT, this prospective study represents a novel approach in this area.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * confirmed underlying solid malignant tumor (no germ cell tumor, leukemia, lymphoma) * 1-3 hepatic metastases confirmed by pre-therapeutic MRI * indication for SBRT of 1-3 hepatic metastases * maximum diameter each hepatic metastasis ≤ 5 cm (in case of 3 metastases: sum of diameters ≤ 12 cm) * age ≥ 18 years of age * Karnofsky Performance Score ≥ 60% * ability to lie still on the radiotherapy treatment couch for at least one hour * ability to hold one's breath for more than 25 seconds * for women with childbearing potential, adequate contraception * ability of subject to understand character and individual consequences of the clinical trial * written informed consent (must be available before enrolment in the trial) Exclusion Criteria: * refusal of the patients to take part in the study * patients with primary liver cancer (eg. HCC, CCC) * patients after liver transplantation * impairment of liver function to an extent contraindicating radiotherapy (to the discretion of the treating radiation oncologist) * active acute hepatic/biliary infection (e.g. hepatitis, cholangitis, cholecystitis) * previous radiotherapy of the hepatobiliary system, if previous and current target volumes overlap MAESTRO Study Studienprotokoll Seite 25 von 54 Version 1.0 vom 17.12.2020 * patients who have not yet recovered from acute toxicities of prior therapies * claustrophobia * pregnant or lactating women * contraindications against performing contrast-enhanced MRI scans (pacemakers, other implants making MRI impossible, allergy to gadolinium (GD)-based contrast agent) * participation in another competing clinical study or observation period of competing trials
Where it's running
-
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany Recruiting
Study contacts
- Study coordinator: Jakob Liermann, PD Dr
- Email: jakob.liermann@med.uni-heidelberg.de
- Phone: +496221 56
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.