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

Hepatic Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04332419
• Other study ID #: CASE13219
• Status: Completed
• Phase: N/A
• Start date: March 3, 2020
• Est. completion date: September 21, 2020

Study information

• Verified date: June 2022
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 21, 2020
• Est. primary completion date: September 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Malignancies
• Neoplasms

Intervention

Device:
• PET/CT
Standard Imaging
• PET/MR
Additional Imaging

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

Locations

Country	Name	City	State
United States	Cleveland Clinic, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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