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

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

Sponsors

Lead sponsor: Case Comprehensive Cancer Center

Source Case Comprehensive Cancer Center
Brief Summary

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.

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.

Overall Status Recruiting
Start Date March 3, 2020
Completion Date December 31, 2020
Primary Completion Date December 31, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Reproducibility coefficient (RDC) between the two imaging modalities in liver tumor tissues Within 1 week of intervention
Secondary Outcome
Measure Time Frame
RDC between the two imaging modalities in background liver tissues Within 1 week of intervention
Enrollment 12
Condition
Intervention

Intervention type: Device

Intervention name: PET/CT

Description: Standard Imaging

Arm group label: PET/CT & PET/MR

Intervention type: Device

Intervention name: PET/MR

Description: Additional Imaging

Arm group label: PET/CT & PET/MR

Intervention type: Radiation

Intervention name: SIRT with Y-90

Description: SIRT with Y-90 for palliative treatment of the liver malignancy.

Arm group label: PET/CT & PET/MR

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Ram Gurajala, MD Principal Investigator Cleveland Clinic, Case Comprehensive Cancer Center
Overall Contact

Last name: Ram Gurajala, MD

Phone: 1-866-223-8100

Email: [email protected]

Location
facility status contact investigator
Cleveland Clinic, Case Comprehensive Cancer Center Recruiting Ram Gurajala, MD 866-223-8100 [email protected] Samir Abraksia, MD Principal Investigator
Location Countries

United States

Verification Date

April 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: PET/CT & PET/MR

Arm group type: Experimental

Description: 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.

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov