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

NCT04332419 | Completed Results FDA Device

• 1 other identifier: CASE13219
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Malignancies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• RDC Between the Two Imaging Modalities in Background Liver Tissues

  Post-op day 0, 1 hour apart

Study Arms (1)

PET/CT & PET/MR

EXPERIMENTAL

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; Device: PET/MR; Radiation: SIRT with Y-90

Interventions

PET/CT DEVICE

Standard Imaging

PET/CT & PET/MR

PET/MR DEVICE

Additional Imaging

PET/CT & PET/MR

SIRT with Y-90 RADIATION

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

PET/CT & PET/MR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44122, United States

Location

MeSH Terms

Interventions

Positron Emission Tomography Computed Tomography; Sirtuins; Yttrium-90

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Group III Histone Deacetylases; Histone Deacetylases; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; ADP Ribose Transferases; Pentosyltransferases; Glycosyltransferases; Transferases; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Ram Gurajala, MD
• Organization: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

TaussigResearch@ccf.org

1-866-223-8100

Study Officials

• Ram Gurajala, MD

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 2, 2020
• Study Start: March 3, 2020
• Primary Completion: September 21, 2020
• Study Completion: September 21, 2020
• Last Updated: June 22, 2022
• Results First Posted: October 5, 2021

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)