Recruiting NCT07223307

REGULUS: MRI-guided Adaptive SABR for Liver Cancers

Phase II Interventional Liver Cancer Intrahepatic Cholangiocarcinoma Liver Metastases HCC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: MRI-guided adaptive stereotactic ablative body radiotherapy (SABR).
Who it may be relevant to: Registry conditions: Liver Cancer, Intrahepatic Cholangiocarcinoma, Liver Metastases, HCC. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

Phase II Trial of REal Time MRI GUided Adaptive Stereotactic Ablative Radiotherapy for Liver Cancers Using a Single Session, Simulation Free Workflow

Single arm unblinded study of simulation-free MRI-guided SABR with adaptive replanning in one session for treatment of patients with liver cancers

Radiation MRI-guided adaptive stereotactic ablative body radiotherapy (SABR)
A single fraction of MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) will be delivered using the MRIdian system. Treatment includes adaptive planning based on daily MRI imaging to update tumor and organ-at-risk contours and optimize the radiation dose. On the day of treatment, Eovist contrast is administered 20 minutes before therapy to enhance tumor visualization. Patients perform an inspiratory breath hold during radiation delivery to minimize motion. The total dose is 30-40

Secondary outcome measures (7)

Rate of Grade ≥ 2 Gastrointestinal (GI) Adverse Events [Time frame: Within 90 days of completing SABR]
Rate of Grade ≥ 2 Radiation Pneumonitis [Time frame: Within 90 days of completing SABR]
Rate of Grade ≥ 2 Chest Wall Toxicity [Time frame: Within 90 days of completing SABR]
Change from Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life Score up to 1 Year Post-SABR [Time frame: Up to 1 year post-SABR]
Change from Baseline in FACT-Hep Total Score up to 1 Year Post-SABR [Time frame: Up to 1 year post-SABR]
Change from Baseline in COST-FACIT Total Score up to 1 Year Post-SABR [Time frame: Up to 1 year post-SABR]
Rate of Patients With Total Delivery Time > 120 Minutes [Time frame: Baseline]

Histologically confirmed HCC, intrahepatic cholangiocarcinoma, or metastatic cancer. In the case of suspected HCC in patients with known cirrhosis, noninvasive criteria recommended by the European Association for the Study of Liver Diseases (lesion > 1 cm with arterial phase hyperenhancement and venous phase washout) or LI-RADS score of 5 may be used
≥ 18 years old at time of study enrollment
Child-Pugh A status
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Life Expectancy > 6 months
For women of childbearing potential or who are not postmenopausal (see Appendix F for Definition of Menopausal Status), a negative urine or serum pregnancy test must be done.
Ability to understand and the willingness to provide written informed consent.
Patients treated with prior liver-directed therapies with the exception of radioembolization are eligible for this study if they otherwise meet eligibility criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

NCT: NCT07223307 · IRB-82587