Comparison of Yttrium-90 Absorbed Doses Using PET/CT Versus PET/MR Imaging for Hepatic Malignancies

Comparison of Yttrium-90 Absorbed Doses Using PET/CT Versus PET/MR Imaging in Patients Undergoing Selective Internal Radiation Therapy for Hepatic Malignancies

The purpose of this study is to compare the results of positron emission tomography/computer tomography (PET/CT) to positron emission tomography/magnetic resonance imaging (PET/MRI) to help determine any added advantage of one over the other in relation to a tumor which might assist in further management plans.

Study Overview

• Status: Completed
• Conditions: Hepatic Malignancies
• Intervention / Treatment: Device: PET/CT; Device: PET/MR; Radiation: SIRT with Y-90

Detailed Description

Participants in this study will undergo PET/CT (standard imaging) and PET/MR (additional imaging), within 6 hours after SIRT with Y-90 for palliative treatment of the liver malignancy. Patients will be randomized to receive either of the imaging modalities first, based on the availability of the imaging device, and less than 1 hour apart. Upon acquirement and construction of PET/CT and PET/MR images, a software (MIM SurePlan LiverY90) would be utilized for semi-automatic determination of the liver/tumor contours and calculation of the Y-90 absorbed doses (Gy) in the regions of interest (including within tumor and background liver outlines) using the Local Deposition Method.

The primary objective of this study is to assess the agreement between post-Y-90 RE absorbed doses (Gy) in the liver tumor tissues based on PET/CT versus PET/MR imaging. This would permit the comparison of Y-90 tumor absorbed doses, acquired from PET/MR, with the current standard of care PET/CT imaging to verify the data consistency and to validate its application for the prediction of tumor response to treatment.

The secondary objective of this study is to assess the agreement between post-Y-90 RE absorbed doses (Gy) in the background liver tissues (surrounding tumors), based on PET/CT versus PET/MR imaging. This would permit the comparison of Y-90 background liver absorbed doses, acquired from PET/MR, with the current standard of care PET/CT imaging to verify the data consistency and to validate its application for the prediction of dose toxicity.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Cleveland Clinic, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient has a liver malignancy and is scheduled for SIRT with Y-90; AND
• The patient is an adult, self-competent, and able to provide informed consent to participate in the study

Exclusion Criteria:

• The patient loses competence, has a condition that questions their ability to provide informed consent independently (e.g. cannot communicate in English), or withdraws consent to participate within any time in the study period; OR
• The patient is not eligible to undergo MRI due to the presence of metal devices or implants in their body; OR
• Both imaging modalities cannot take place within 6 hours after Y-90 RE; OR
• Both imaging modalities cannot take place within 1 hour apart from each other

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PET/CT & PET/MR; One-time PET/MR imaging in addition to the standard PET/CT imaging, both performed on the same day of the treatment procedure (Selective Internal Radiation Therapy Y-90 RE). Participants will be randomized to receive either of the imaging modalities first, based on the availability of the imaging device, and less than 1 hour apart.	Device: PET/CT; Standard Imaging; Device: PET/MR; Additional Imaging; Radiation: SIRT with Y-90; SIRT with Y-90 for palliative treatment of the liver malignancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility Coefficient (RDC) Between the Two Imaging Modalities in Liver Tumor Tissues	RDC between the two imaging modalities for post-Y-90 Radioembolization (RE) absorbed doses (Gy) in the liver tumor tissues The RDC is the minimum difference between the two measurements that can be considered a true difference, with 95% confidence.	Post-op day 0, 1 hour apart

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RDC Between the Two Imaging Modalities in Background Liver Tissues	RDC between the two imaging modalities for post-Y-90 RE absorbed doses (Gy) in the background liver tissues The RDC is the minimum difference between the two measurements that can be considered a true difference, with 95% confidence.	Post-op day 0, 1 hour apart

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Ram Gurajala, MD, Cleveland Clinic, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2020
• Primary Completion (Actual): September 21, 2020
• Study Completion (Actual): September 21, 2020

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CASE13219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Team will be sharing study results but not IPD because of HIPAA regulations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes