This study is being done to help doctors improve how they treat liver tumors that cannot be removed by surgery or treated with standard ablation techniques. The researchers want to find out the best amount of radiation that needs to be delivered to completely destroy (or ablate) parts of the liver that have cancer.
Currently, doctors use Yttrium-90 (Y90) radiation segmentectomy, a treatment that delivers tiny radioactive beads into the blood vessels feeding the liver tumor. These beads give off radiation that helps kill the cancer cells from the inside, right where the tumor is located. This approach allows doctors to target the tumor very precisely, while keeping the rest of the liver as healthy as possible. However, the exact dose needed to fully ablate a tumor without damaging healthy liver tissue is not well established. To answer this, the study team will use specialized imaging before and after treatment to evaluate how the radiation is distributed in the liver and how the liver responds over time. These imaging procedures include PET/CT or PET/MRI scans, which are standard medical imaging tests that are not considered experimental. During these scans, a small amount of a safe radioactive substance is injected into a participant's vein. This helps show where the Y90 beads are located in the participant's liver. In a PET/CT scan, two types of imaging are performed during the same session. The PET scan detects signals from the radioactive substance and shows how the participant's liver is functioning at a molecular level. The CT scan, which uses x-rays to create detailed cross-sectional images of the body, provides a precise anatomical map that helps localize these functional signals. Together, they give a clear picture of both the structure and activity within the liver. PET/MRI works similarly but uses magnetic fields and radio waves instead of x-rays. It combines the functional information from the PET scan with the highly detailed soft-tissue images from MRI, which can be especially useful in evaluating the liver. Both imaging techniques are done during a single visit, with the PET component typically performed at the same time as the CT or MRI, depending on which machine is used. Participants will also undergo a liver MRI with dual contrast using Eovist and extracellular gadolinium, another standard imaging procedure. MRI uses magnets and radio waves to take detailed pictures of the liver. Eovist is a special dye injected into a participant's vein during the scan that helps highlight liver tissue and shows how well different parts of the liver are functioning. Extracellular gadolinium is a more general contrast agent that enhances blood vessels and tissues, providing complementary information. This imaging helps the doctors confirm whether the tumor area was completely treated. The goal is to determine the safest and most effective dose of radiation to fully treat cancer while preserving healthy liver tissue. This information may help doctors treat future patients more precisely and safely. Yttrium-90 and the imaging methods used in this study, including PET/CT, PET/MRI, and dual contrast MRI, are FDA-approved.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The objective of this study is to define an optimal "ablative dose" range for Y90 Radiation Segmentectomy that achieves complete sectoral ablation detectable on dual contrast MRI and to determine whether this dose-response relationship differs between cirrhotic and non-cirrhotic patients.
Northwestern University
Chicago, Illinois, United States
RECRUITINGAblative Dose Threshold for Y90 Radiation Segmentectomy
To prospectively define the "ablative dose" threshold for Y90 Radiation Segmentectomy (RS) using post-treatment PET dosimetry and hepatobiliary phase MRI
Time frame: From enrollment to the end of post-treatment Y90 12 month follow up visit
Impact of Cirrhosis on Ablative Dose Requirements
To determine whether cirrhotic patients require a higher threshold dose for ablation compared to non- cirrhotic patients
Time frame: From enrollment to enrollment to post-treatment Y-90 12 month follow-up visit
Correlation of Y90 Dose with Imaging Biomarkers
To evaluate the correlation between delivered Y90 dose and imaging biomarkers, including signal loss on hepatobiliary phase MRI, ablative margins, extracellular volume fraction, and perfusion changes
Time frame: Assessed at 1, 4-9, and 12 month follow up visits
Tumor Response and Time-to-Progression Assessment
To assess tumor response by mRECIST and determine time to progression (TTP)
Time frame: From enrollment to end of post-treatment Y-90 12 month follow up visit
Safety and Tolerability of Escalating Y90 Doses
To assess the safety and tolerability of escalating segmental Y90 doses (200- 500 Gy) using Bayesian optimal interval (BOIN) dose-escalation design under Data and Safety Monitoring Committee (DSMC) oversight
Time frame: From enrollment to end of post-treatment Y90 12 month follow up visit
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