REGULUS: MRI-guided Adaptive SABR for Liver Cancers

Stanford University

Status and phase: Enrolling; Phase 2

Conditions: Intrahepatic Cholangiocarcinoma; Liver Metastases; HCC; Liver Cancer

Treatments: Radiation: MRI-guided adaptive stereotactic ablative body radiotherapy (SABR)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07223307

IRB-82587

Details and patient eligibility

About

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

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

62 participants in 1 patient group

MRI-guided Adaptive Stereotactic Ablative Body Radiotherapy (SABR)

Experimental group

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.

Treatment:

Radiation: MRI-guided adaptive stereotactic ablative body radiotherapy (SABR)