Clinical trial · Interventional
REGULUS: MRI-guided Adaptive SABR for Liver Cancers
Phase II Trial of REal Time MRI GUided Adaptive Stereotactic Ablative Radiotherapy for Liver Cancers Using a Single Session, Simulation Free Workflow
NCT07223307CI-TRIAL-00102750recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Single arm unblinded study of simulation-free MRI-guided SABR with adaptive replanning in one session for treatment of patients with liver cancers
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HCC | — | UNRESOLVED | — |
| Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Liver Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI-guided Adaptive Stereotactic Ablative Body Radiotherapy (SABR)
- description
- Participants will receive a single fraction of MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) using the MRIdian system. Treatment includes daily adaptive planning based on MRI to optimize dose delivery to the tumor and minimize dose to surrounding normal tissue. Eovist contrast is administered before treatment to enhance visualization. Patients perform an inspiratory breath hold during radiation delivery to minimize motion.
- interventionNames
- Radiation: MRI-guided adaptive stereotactic ablative body radiotherapy (SABR)
Primary outcomes (1)
- measure
- 1-year Overall Survival (OS)
- timeFrame
- 1 year after SABR
- description
- Overall survival will be defined as the time from treatment to death from any cause. Patients alive at the time of analysis will be censored at last follow-up.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Prior treatment with radioembolization * Cytotoxic chemotherapy or investigational agent within 1 week of SABR * Prior radiotherapy overlapping with study treatment site * Female patients who are pregnant * Contraindication to having an MRI scan or inability to tolerate MRI * Presence of a pacemaker or other implanted cardiac device * Direct tumor extension into the stomach, duodenum, small bowel or large bowel * Patient unable to breath hold \> 15 seconds
References
Publications (0)
Data not yet available
No reference posted for this study.