Optimizing Y90 Therapy for Radiation Lobectomy

NCT04390724 | Recruiting FDA Device

• 1 other identifier: STU00209629
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

HCC; Resection; Transplant; Metastatic Cancer; Adult Primary Liver Cancer

Keywords

HCC; Y90 Radioembolization; Liver Resection; Liver Transplant; Liver Cancer

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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).

  3 years

Study Arms (2)

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

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

Device: Y90 radioembolization

Interventions

Y90 radioembolization DEVICE

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

Also known as: Patient Group 1: Y90 Standard-of-Care, Patient Group 2: Y90 Dose determined by results from Group 1

Patient Group 1: Y90 Standard-of-Care; Patient Group 2: Y90 Dose determined by results from Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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%
• 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

You may not qualify if:

• 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:
• 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
• mg 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

Sponsors & Collaborators

• Northwestern University: lead
• Mayo Clinic: collaborator

Study Sites (2)

Mayo Clinic

Jacksonville, Florida, 32224, United States

ACTIVE NOT RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Group 1 patients consent to have an optional study-specific liver parenchymal biopsy Group 2 have their blood drawn to measure circulating trophic factors.

MeSH Terms

Conditions

Neoplasm Metastasis; Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Robert Lewandowski, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Jeremy Collins, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Lewandowski, MD

CONTACT

312-695-9121; r-lewandowki@northwestern.edu

Kristie Kennedy, MA

CONTACT

312-695-4023; kristie.kennedy@northwestern.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology, Medicine, and Surgery

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 15, 2020
• Study Start: July 17, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)