Status:
NOT_YET_RECRUITING
REGULUS: MRI-guided Adaptive SABR for Liver Cancers
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Viewray Inc.
Conditions:
Liver Cancer
Intrahepatic Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Single arm unblinded study of simulation-free MRI-guided SABR with adaptive replanning in one session for treatment of patients with liver cancers
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT07223307
Start Date
December 1 2025
End Date
January 1 2030
Last Update
October 31 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University
Palo Alto, California, United States, 94304