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Precision radiation zaps untreatable liver tumors in tiny pilot study

NCT ID NCT04903548

Disease control Sponsor: Methodist Health System Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a procedure called selective internal radiation therapy (SIRT) using Y-90 resin microspheres (SIR-Spheres) in one patient with liver cancer that could not be removed by surgery. The goal was to see if a flexible dosing approach could improve outcomes like tumor shrinkage, survival, and treatment costs. The study is complete but very small, so its findings are preliminary.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Y-90 resin microspheres (SIR-Spheres)
What this could lead to
If successful, this approach could offer a more precise way to deliver radiation to liver tumors, potentially improving tumor control and survival while reducing side effects.
What could go wrong
This was a very small, single-center study with only one participant, so results may not apply to others. The procedure carries risks like radiation damage to healthy liver tissue or lungs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1 person

The number who actually took part.

Started

Jan 2021

Finished

Oct 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All patients diagnosed with unresectable HCC in two of fewer hepatic segments at MDMC who undergo at least one SIRT procedure with Y-90 resin microspheres

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 years or older * All patients diagnosed with unresectable HCC in two of fewer hepatic segments at MDMC who undergo at least one SIRT procedure with Y-90 resin microspheres (SIR-Spheres®, Sirtex Medical Limited, Sydney, Australia) will be included in data capture. HCC is considered unresectable if it is multifocal or bilobar, or if the patient has malignant portal vein thrombosis, portal hypertension, or decompensated liver disease (Child-Pugh B or C). * Eligible cases for inclusion are those that would have undergone Y-90 resin SIRT and had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; platelets \>60,000; creatinine \<2 mg/dL; bilirubin \<2 mg/dL; and international normalized ratio (INR) \<1.2. Exclusion Criteria: * Subjects that do not meet the inclusion criteria * Patients are not eligible for SIRT if they had any extrahepatic disease; contraindication to hepatic artery catheterization such as vascular abnormalities, bleeding diathesis, allergy to contrast dye, concurrent malignancy, refractory ascites, previous external beam radiation, or evidence of any uncorrectable flow to the gastrointestinal tract; or greater than 30 Gy of radiation estimated to be delivered to the lung based on angiography or Tc-99 microaggregated albumin scan (shunt fraction of 20% or greater).

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatocellular carcinoma

Contacts and locations

Locations

  • Methodist Dallas Medical Center

    Dallas, Texas, 75203, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.