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

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.

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.

Although the study uses radiation-emitting imaging devices (PET/CT and SPECT) and standard-of-care Y-90 radioembolization, the clinical investigation does not study the performance, effect, safety, effectiveness, design, or intended use of an FDA-regulated device product. The research objectives are limited to characterization of radiation dose distribution and correlation of dosimetry with clinical outcomes; therefore, the study does not "Study a U.S. FDA-regulated Device Product" within the meaning of 42 CFR Part 11

Inclusion Criteria:

• Patients must have liver-dominant or liver-only metastatic disease from any primary histology; patients with primary hepatocellular or biliary cancer are also eligible
• Patients must be clinical candidates for radioembolization with either SIR-spheres or TheraSphere due to metastatic or primary malignancies of the liver
• Women of child bearing potential must have a negative serum pregnancy test no more than 72 hours prior to registration
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
• Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of medical information
• Complete blood count (CBC) and chemistry panel (CMP) no greater than 4 weeks prior to visit 1
• Diagnostic imaging of the abdomen utilizing either CT with contrast, magnetic resonance imaging (MRI), or PET/CT no greater than 4 weeks prior to visit 1

Exclusion Criteria:

• Patients not undergoing radioembolization to the liver
• Women of childbearing potential (WOCBP) and men who refuse to comply with appropriate contraception
• Women who are either pregnant or breast feeding