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

NCT04390724 RECRUITING

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.

Details

Lead sponsor	Northwestern University
Status	RECRUITING
Enrolment	104
Start date	2020-07-17
Completion	2026-07

Conditions

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

Interventions

• Y90 radioembolization

Primary outcomes

• Patient Group 1: Y90 Glass Microspheres — 2 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 distribution — 2 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 Biomarkers — 3 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 Resection — 3 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).

Countries

United States