NCT02088775

PET-CT in Determining the Radioembolization Dose Delivered to Patients With Liver Metastasis, Primary Liver Cancer, or Biliary Cancer

Intrinsic Dosimetry for Radioembolization Utilizing PET-CT Imaging Data: A Prospective Registry Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies positron emission tomography (PET)-computed tomography (CT) in determining the radiation dose delivered with radioactive spheres to patients with liver metastasis or primary liver or biliary cancer. Comparing results of diagnostic procedures dose before and after delivery of radioactive spheres to the liver may help determine radioembolization dose and plan the best treatment for liver metastasis or primary liver or biliary cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the relationship between radiation dose to 70% of the tumor volume as determined by post-treatment positron emission tomography (PET)-computed tomography (CT) and local control at 6 months. SECONDARY OBJECTIVES: I. To evaluate the ability of PET-CT to reproducibly determine dose to tumor, normal liver, and other surrounding organs. II. To determine the stability of microsphere location by examining the changes in dose in a subset of patients with PET-CT scans performed on day 0 and day 1. III. To determine the relationship of dose predicted by technetium-99m (Tc-99m) labeled Macro-aggregated albumin (MAA) imaged using single-photon emission computed tomography (SPECT) versus post-treatment dosimetry. IV. To determine the effect of dose delivered on local control and normal tissue complications. V. To measure the perfusion of the tumor for correlation with dose deposition, based on arterial phase CT measurements. OUTLINE: Patients undergo PET-CT scan before and after standard radioembolization on day 0. A subset of patients undergo PET-CT scan on day 1, 24 hours after the day 0 post-treatment PET-CT. After completion of study treatment, patients are followed up at 1 week, 1 and 3 months, every 3 months for 1 year, every 6 months for 1 year and then annually for 3 years.

Conditions

• Adult Primary Hepatocellular Carcinoma
• Advanced Adult Primary Liver Cancer
• Metastatic Extrahepatic Bile Duct Cancer
• Recurrent Adult Primary Liver Cancer
• Recurrent Extrahepatic Bile Duct Cancer
• Stage D Adult Primary Liver Cancer (BCLC)
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
PROCEDURE	PET scan	Undergo PET-CT scan
PROCEDURE	CT Scan	Undergo PET-CT scan
PROCEDURE	hepatic artery embolization	Undergo standard radioembolization

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-08-08
• Completion: 2021-07-30
• First posted: 2014-03-17
• Last updated: 2024-01-16

Locations

1 site across 1 country: United States