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NCT04390724

Optimizing Y90 Therapy for Radiation Lobectomy

Active, Not Recruiting
Not specifiedAges 18+Observational
Northwestern University
~104 participants
Updated 2026-09-16 on ClinicalTrials.gov
What's tested:Y90 radioembolization

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient Group 1: Y90 Glass Microspheres
Measured over 2 years
+3 more outcomes measured

Conditions

HCC
Resection
Transplant
Metastatic Cancer
Adult Primary Liver Cancer

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Hepatocellular Carcinoma

NCT04390724

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic

    Jacksonville, Floridano site contact published

  • Northwestern University

    Chicago, Illinoisno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Robert Lewandowski, MD · PRINCIPAL_INVESTIGATOR · Northwestern University
  • Jeremy Collins, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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
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

What this trial measures

  • Patient Group 1: Y90 Glass Microspheres2 years

    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.

  • Patient Group 1: Sphere distribution2 years

    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.

  • Patient Group 2: Quantitative Imaging Radiologic Biomarkers3 years

    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.

  • Patient Group 2: HCC Resection3 years

    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).