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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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 Summary:

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.

Current Primary Outcome:

• Radiation dose to 70% of the tumor volume, evaluated using PET-CT [ Time Frame: Up to day 1 ]
  Standard summary measures such as means, medians, ranges, and standard deviations will be used to characterize the dosages received by tumor and other tissue. The relationship between radiation dose and local control will be determined using regression models with Generalized Estimating Equations (GEE) to account for within-patient correlation. Logistic regression will be used to adjust for potentially confounding factors such as tumor volume, primary histology, and SIR-Spheres versus Therasphere intervention.
• Local control [ Time Frame: At 6 months ]
  The relationship between radiation dose and local control will be determined using regression models with GEE to account for within-patient correlation.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Ability of PET-CT to reproducibly determine dose to tumor, normal liver, and other surrounding organs [ Time Frame: Up to day 1 ]
  Standard summary measures such as means, medians, ranges, and standard deviations will be used to characterize the dosages received by tumor and other tissue.
• Side effects of radiation dose to healthy tissue such as fatigue, nausea, pain, and elevated liver function tests [ Time Frame: Up to 5 years ]
  Each side effect will be characterized as present or absent. The relationship between radiation dose to the relevant type of healthy tissue and each side effect will be tested.
• Distribution of activity measured by PET-CT [ Time Frame: Up to day 1 ]
  Differences between PET-CT and MAA doses, and present the data graphically will be calculated and presented graphically. The method proposed by Bland & Altman (2007) will be used to assess the agreement between the two methods.
• Distribution predicted by T-99m labeled MAA [ Time Frame: Baseline ]
  Differences between PET-CT and MAA doses, and present the data graphically will be calculated and presented graphically. The method proposed by Bland & Altman (2007) will be used to assess the agreement between the two methods.
• Change in dose measured by PET-CT scan [ Time Frame: Day 0 to day 1 ]

Original Secondary Outcome: Same as current

Information By: Fox Chase Cancer Center

Dates:
Date Received: March 13, 2014
Date Started: February 2014
Date Completion: January 2018
Last Updated: January 24, 2017
Last Verified: January 2017