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

January 11, 2024 updated by: Fox Chase Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic: PET scan - CT scan
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.
Procedure: PET scan
Undergo PET-CT scan
Other Names:
  • FDG-PET, positron emission tomography, emission computed
Procedure: CT Scan
Undergo PET-CT scan
Other Names:
  • computed tomography, computed
Procedure: hepatic artery embolization
Undergo standard radioembolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to day 1
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.
At 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to day 1
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.
Up to 5 years
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.
Up to day 1
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.
Baseline
Change in dose measured by PET-CT scan
Time Frame: Day 0 to day 1
Day 0 to day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fox Chase Cancer Center

Investigators

  • Principal Investigator: Joshua Meyer, MD, Fox Chase Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

August 8, 2016

Study Completion (Actual)

July 30, 2021

Study Registration Dates

First Submitted

March 13, 2014

First Submitted That Met QC Criteria

March 14, 2014

First Posted (Estimated)

March 17, 2014

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERP-RT-060
  • IRB#13-030 (Other Identifier: Fox Chase Cancer Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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