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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-03

Study Completion Date

2020-09-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatic Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PET/CT

Intervention Type DEVICE

Standard Imaging

PET/MR

Intervention Type DEVICE

Additional Imaging

SIRT with Y-90

Intervention Type RADIATION

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

Interventions

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PET/CT

Standard Imaging

Intervention Type DEVICE

PET/MR

Additional Imaging

Intervention Type DEVICE

SIRT with Y-90

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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No