Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05027711

Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases

Led by University Hospital Heidelberg · Updated on 2026-03-10

90

Participants Needed

1

Research Sites

442 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed solid malignant tumor (excluding germ cell tumor, leukemia, lymphoma)
  • 1 to 3 hepatic metastases confirmed by pre-treatment MRI
  • Indication for stereotactic body radiotherapy (SBRT) of 1 to 3 hepatic metastases
  • Maximum diameter of each metastasis 64 5 cm; if 3 metastases, sum of diameters 64 12 cm
  • Age 18 years or older
  • Karnofsky Performance Score of 60% or higher
  • Ability to lie still on the radiotherapy treatment couch for at least one hour
  • Ability to hold breath for more than 25 seconds
  • For women of childbearing potential, use of adequate contraception
  • Ability to understand the study and its individual consequences
  • Provided written informed consent before enrollment
Not Eligible

You will not qualify if you...

  • Patient refusal to participate in the study
  • Primary liver cancer (e.g., hepatocellular carcinoma, cholangiocarcinoma)
  • History of liver transplantation
  • Liver function impaired to a degree contraindicating radiotherapy
  • Active acute liver or biliary infections (e.g., hepatitis, cholangitis, cholecystitis)
  • Previous radiotherapy to the hepatobiliary system with overlapping treatment areas
  • Not fully recovered from acute toxicities of prior therapies
  • Claustrophobia
  • Pregnant or breastfeeding women
  • Contraindications to contrast-enhanced MRI (e.g., pacemakers, incompatible implants, gadolinium allergy)
  • Participation in another competing clinical study or observation period of competing trials

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, Germany, 69120

Actively Recruiting

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Research Team

J

Jakob Liermann, PD Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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