PET-CT in Determining the Radioembolization Dose Delivered to Patients With Liver Metastasis, Primary Liver Cancer, or Biliary Cancer
NCT ID: NCT02088775
Last Updated: 2024-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2014-02-28
2021-07-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
PET scan
Undergo PET-CT scan
CT Scan
Undergo PET-CT scan
hepatic artery embolization
Undergo standard radioembolization
Interventions
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PET scan
Undergo PET-CT scan
CT Scan
Undergo PET-CT scan
hepatic artery embolization
Undergo standard radioembolization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Women of childbearing potential (WOCBP) and men who refuse to comply with appropriate contraception
* Women who are either pregnant or breast feeding
18 Years
ALL
No
Sponsors
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Fox Chase Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Joshua Meyer, MD
Role: PRINCIPAL_INVESTIGATOR
Fox Chase Cancer Center
Locations
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB#13-030
Identifier Type: OTHER
Identifier Source: secondary_id
ERP-RT-060
Identifier Type: -
Identifier Source: org_study_id
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