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Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MRI-guided Adaptive Stereotactic Ablative Body Radiotherapy (SABR) 		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.
  • 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 Gy delivered in one fraction using external beam techniques.

Recruiting Locations

Stanford University
Palo Alto 5380748, California 5332921 94304
Contact:
Eleanor Brown
650-497-8966
eleanor9@stanford.edu

More Details

Status
Recruiting
Sponsor
Stanford University

Study Contact

Eleanor Brown
650-497-8966
eleanor9@stanford.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.