Y90 Radiation Segmentectomy vs SBRT for HCC

  • End date
    May 8, 2024
  • participants needed
  • sponsor
    Indiana University
Updated on 8 September 2021
serum bilirubin


The proposed study is a single site, prospective, randomized pilot study to assess the feasibility of recruitment of patients into a trial evaluating the efficacy and tolerability of selective transarterial Y90 radioembolization (radiation segmentectomy) versus stereotactic body radiation therapy (SBRT) for solitary early stage ( 3cm) hepatocellular carcinoma (HCC).

Condition HEPATIC NEOPLASM, HEPATOCELLULAR CARCINOMA, Adenocarcinoma, liver cell carcinoma, Liver Cancer, Malignant Adenoma
Treatment stereotactic body radiation therapy, Yttrium-90 Radiation Segmentectomy
Clinical Study IdentifierNCT04235660
SponsorIndiana University
Last Modified on8 September 2021


Yes No Not Sure

Inclusion Criteria

Ability to provide written informed consent and HIPAA authorization
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 18 years at time of informed consent
Solitary HCC (3 cm) diagnosed by imaging (LI-RADS 4-5) or histology
Childs-Pugh score 7
ECOG performance status 0-1
Tumor location/characteristics eligible for either SBRT or Y90 therapy as deemed by local tumor board
Adequate organ function defined as
serum bilirubin < 4.0 mg/dL
albumin > 2 g/dL

Exclusion Criteria

Any prior locoregional therapy to the target tumor
Any prior radiation therapy to the liver
Pregnancy or lactation: Women of childbearing potential must have a negative pregnancy test within 14 days of protocol registration. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following
i. Has undergone a hysterectomy or bilateral oophorectomy; or ii. Has been naturally amenorrheic for at least 24 consecutive months
Known severe allergic reaction (anaphylaxis) to iodinated contrast
Coagulopathy (platelets < 50 K/mm3 and/or INR > 2) not correctable by transfusion
Macrovascular invasion or extrahepatic HCC
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note