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Radiation boosts liver size, paving way for cancer surgery

NCT ID NCT04390724

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Updated 4 times

Summary

This study is for people with liver cancer who need surgery but don't have enough healthy liver left. Doctors use a special radiation treatment (Y90) to help the liver grow larger. Once the liver is big enough, patients can have surgery to remove the cancer. The study compares standard care with an optimized dose to find the best approach.

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

104 people

The number who actually took part.

Started

Jul 2020

Expected to finish

Nov 2026

An estimate. End dates often move.

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

Patients 18 years and older with HCC who are eligible to receive standard-of-care Y90 radioembolization and are hepatic resection candidates with inadequate future liver remnant

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: 1. Patients must have been diagnosed with HCC confirmed by histology or must meet one of the following American Association for the Study of Liver Diseases (AASLD) guidelines: * AFP \>200 and radiological evidence (arterial hypervascularity) of lesion \> 2 cm does not require biopsy * Two imaging modalities (triphasic CT, MRI, ultrasound, angiography) demonstrating arterial hypervascularity in the background of cirrhosis does not require biopsy * One imaging modality with a lesion with arterial hypervascularity with wash out in early or delayed venous phase, does not require a biopsy 2. Child-Pugh stage A 3. Future Liver Remnant (FLR) of \< 40% 4. ECOG Performance Status 0-1 5. Bilirubin ≤ 3.0 mg/dl- Treatment may proceed if the Bilirubin is elevated if the tumor may be isolated from a vascular standpoint 6. Creatinine ≤ 2.0 mg/dl 7. ANC ≥ 1.5 K/uL 8. Platelets \> 25 K/uL 9. Patient is willing participate in this study and has signed the consent 10. For Group 2 patients only: * Patients planned Y90 dose and embolic load is found to fall within the optimal dose and embolic load size from data from Group 1 patients Exclusion Criteria: 1. Patient must not be pregnant NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months) 2. For Patients in Group 2 only: * Patients who have contraindications to MRI: * Patients that are claustrophobic and haven't been able to tolerate an MRI in the past. (Patients with mild claustrophobia are eligible and have the option to take 1mg oral Lorazepam prior to the MRI, if needed) * Allergy to gadolinium-containing contrast media * Patients with a pacemaker, metallic clip, aneurysm clips, shrapnel fragments, etc. * Patients with an eGFR \< 30 mL/min/m² 3. Must not have any significant life-threatening extra-hepatic disease or life- threatening secondary malignancies, including patients who are on dialysis, have unresolved diarrhea, have serious unresolved infections including patients who are known to be HIV positive or have acute HBV or HCV 4. Must not have any contraindications to angiography and selective visceral catheterization such as bleeding diathesis or coagulopathy that is not correctable by usual therapy of hemostatic agents (e.g. closure device) 5. Must not have any co-morbid disease or condition that would place the patient at undue risk and preclude safe use of TheraSphere treatment, in the Investigator's judgment 6. History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically \-

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

More trials for these conditions

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