Yttrium-90 Radiation Lobectomy: Dose Optimization and Prediction of FLR Hypertrophy to Enable Resection of HCC

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
Northwestern University
RECRUITING
Chicago
Contact Information
Primary
Robert Lewandowski, MD
r-lewandowki@northwestern.edu
312-695-9121
Backup
Kristie Kennedy, MA
kristie.kennedy@northwestern.edu
312-695-4023
Time Frame
Start Date: 2020-07-17
Estimated Completion Date: 2026-07
Participants
Target number of participants: 104
Treatments
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
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
Related Therapeutic Areas
Sponsors
Collaborators: Mayo Clinic
Leads: Northwestern University

This content was sourced from clinicaltrials.gov

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