NCT05027711 Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases
| NCT ID | NCT05027711 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital Heidelberg |
| Condition | Hepatic Metastasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2021-08-12 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2021-08-12 with a primary completion date of 2029-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Stereotactic body radiotherapy (SBRT) is an established local treatment method for patients with hepatic oligometastases. Liver metastases often occur in close proximity to radiosensitive organs at risk (OARs). This limits the possibility to apply sufficiently high doses needed for optimal local control. MR-guided radiotherapy (MRgRT) is expected to hold potential to improve hepatic SBRT by offering superior soft-tissue contrast for enhanced target identification as well as the benefit of daily real-time adaptive treatment. The MAESTRO trial therefore aims to assess the potential advantages of adaptive, gated MR-guided SBRT (MRgSBRT) compared to conventional SBRT at a standard linac using an ITV (internal target volume) approach (ITV-SBRT).
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05027711 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatic Metastasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05027711 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05027711 currently recruiting?
Yes, NCT05027711 is actively recruiting participants. Contact the research team at jakob.liermann@med.uni-heidelberg.de for enrollment information.
Where is the NCT05027711 trial being conducted?
This trial is being conducted at Heidelberg, Germany.
Who is sponsoring the NCT05027711 clinical trial?
NCT05027711 is sponsored by University Hospital Heidelberg. The trial plans to enroll 90 participants.