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

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