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New treatment option for Hepatic Metastasis
Official title Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases
ClinicalTrials.gov ID: NCT05027711
What this study is testing
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Heidelberg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Heidelberg, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.