HCCNCT04390724
Optimizing Y90 Therapy for Radiation Lobectomy
An observational study of HCC and Resection, run by Northwestern University at 2 sites in United States.
Trial summary
HCC resection candidates with inadequate future liver remnant will be enrolled in this study. They will be treated with Y90 radioembolization to help grow the liver enough to undergo liver resection. There will be 2 Patient Groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC, Resection, Transplant
- What is being tested?
- Y90 radioembolization
- Type of treatment
- Medical device
- How many people
- 104 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jul 2020to 27 Nov 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
- Child-Pugh stage A
- Future Liver Remnant (FLR) of < 40%
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- ECOG Performance Status 0-1
- Bilirubin ≤ 3.0 mg/dl- Treatment may proceed if the Bilirubin is elevated if the tumor may be isolated from a vascular standpoint
- Creatinine ≤ 2.0 mg/dl
- ANC ≥ 1.5 K/uL
- Platelets > 25 K/uL
- Patient is willing participate in this study and has signed the consent
- 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
Who cannot join
- 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)
- For Patients in Group 2 only:
- Patients who have contraindications to MRI:
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- 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
- 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
- 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)
- 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
- History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60611
Mayo Clinic
Jacksonville, Florida, 32224
About this study
Official title: Yttrium-90 Radiation Lobectomy: Dose Optimization and Prediction of FLR Hypertrophy to Enable Resection of HCC
HCC resection candidates with inadequate future liver remnant will be enrolled in this study. They will be treated with Y90 radioembolization to help grow the liver enough to undergo liver resection. There will be 2 Patient Groups. The first group of patients will be treated with Y90 dose and embolic load as per standard-of-care. The second group of patients will be treated with the optimal Y90 dose and embolic load found in Patient Group 1.
Read the detailed description
In this study there will be 2 different patient groups 1 and 2 that will consist of 40 and 64 patients, respectively with hepatocellular carcinoma who are eligible for resection and to receive Y90 radioembolization who have inadequate future liver remnant.
Y90 radioembolization uses radioactive beads (microspheres), which are tiny glass particles that are loaded with radiation. The beads are injected into an artery of the liver that supplies blood to the tumor(s). The beads flow to the tumor(s) and become trapped inside. The beads release the Y90 radiation inside the tumor(s).
Liver resection is used to remove the part of the liver that has the HCC tumor(s). It has been shown that Y90 radioembolization can also increase the untreated liver's size and volume. Patients with HCC may be liver resection candidates if they have a large enough liver.
The purpose of this research is to determine if there is an ideal Y90 dose to increase liver volume of the future liver remnant. This research may help determine the best Y90 dose for future patients who need a larger liver to have a liver resection.
Participants in Group 1 will have standard-of-care Y90 radioembolization as well as study-specific optional liver biopsy.
Participants who already have a planned Y90 radioembolization treatment with the dose range established in Group 1 will be enrolled into Group 2. Patient Group 2 will have blood drawn and a quantitative MRI performed at specific timepoints.
The study will last up to 3 months. Participants' health status will be followed up to 5 years.
- Conditions
- HCC, Resection, Transplant, Metastatic Cancer, Adult Primary Liver Cancer
- Being tested
- Y90 radioembolization
- Keywords
- HCC, Y90 Radioembolization, Liver Resection, Liver Transplant, Liver Cancer
- Medical subject headings
- Neoplasm Metastasis, Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y90 radioembolizationDevice
Also called Patient Group 1: Y90 Standard-of-Care, Patient Group 2: Y90 Dose determined by results from Group 1
Patients with HCC who are eligible to receive standard-of-care Y90 radioembolization and are hepatic resection candidates with inadequate future liver remnant
| Study group | Role | What they receive |
|---|---|---|
| Patient Group 1: Y90 Standard-of-Care | The first group of patients will be treated with Y90 dose and embolic load as per standard-of-care Receives: Device: Y90 radioembolization | |
| Patient Group 2: Y90 Dose determined by results from Group 1 | The second group of patients will be treated with the optimal Y90 dose and embolic load found in Patient Group 1 Receives: Device: Y90 radioembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Group 1: Y90 Glass Microspheres
Measure the distribution of Y90 glass microspheres throughout the tumor and non-tumor hepatic parenchyma, as assessed by same day post-radioembolization study-specific non-FDG PET/CT scan.
Measured: 2 years
Patient Group 1: Sphere distribution
Sphere distribution will be correlated with mean lobar absorbed radiation dose, embolic load, and time taken to achieve adequate Future Liver Remnant (>40% of total liver volume) to determine optimal lobar dose and embolic load.
Measured: 2 years
Patient Group 2: Quantitative Imaging Radiologic Biomarkers
Quantitative MRIs and biomarkers drawn will assess the association of circulating and imaging biomarkers on Future Liver Remnant hypertrophy. Tropic factor biomarkers to be drawn include: hepatocyte growth factor, epidermal growth factor, transforming growth factor beta, interleukin-6, tumor necrosis factor alpha, insulin-like growth factor binding protein, vascular endothelial growth factor, platelet derived growth factor, and phosphorus level.
Measured: 3 years
Patient Group 2: HCC Resection
Assess progression-free survival between patients with HCC who underwent resection following Y90 radioembolization and those who presented with an adequate Future Liver Remnant for resection (i.e. who were not treated pre-surgically).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start17 Jul 2020
- Primary completion27 Nov 2026 (estimated)
- Study completion27 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Principal investigator, Robert Lewandowski, Northwestern University
- Investigators
- Robert Lewandowski, MD, Principal investigator, Northwestern UniversityJeremy Collins, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390724
- Sponsor's protocol ID
- STU00209629
- Status last verified
- Sep 2026
- First submitted
- 11 May 2020
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No