Pair Production PET Imaging to Detect Particle Distribution in Patients Undergoing Yttrium-90 Radioembolization

Completed

• Conditions: Carcinoma, Hepatocellular

• Registration Number: NCT02848638
• Lead Sponsor: University of Washington

Brief Summary

The primary goal of the study is to see if the PET/CT will be able to determine the precise location of the Y-90 particles within the liver and within the tumors. We hope to use this information in order to see if these particles distribute evenly throughout large tumors or if the particles go into the tumor which is located in the portal vein.

The secondary goals are threefold. First correlate the distribution of Y90 particles (as demonstrated by PET/CT) with the degree of dead-tumor tissue. Second, see if there is a difference in the Y90 particle's distribution when a low particle load (1-3 million particles) is used compared to when a high particle load (6-8 million particles) is used. Lastly, compare the sensitivity of standard imaging ( bremsstrahlung imaging) currently being used for the Yttrium-90 angioembolization procedure to the sensitivity of the pair production PET research imaging.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2016-03
• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-28
• Study Completion: 2018-03-31
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. UWMC patients over 18 years of age
2. Presence of hepatocellular carcinoma greater than 5 cm OR presence of tumor-associated portal vein thrombosis.
3. Currently undergoing treatment with Yttrium-90 Radioembolization
4. Able to sign informed consent

Exclusion Criteria

1. Patients who are not undergoing treatment with Yttrium-90 Radioembolization
2. Patients unable to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree and distribution of Y90 particle uptake	Within one year of Enrollment completion	To use pair production PET/CT in order to determine the degree and distribution of Y90 particle uptake in patients with large (\>5cm) liver tumors or patients with tumor-associated portal vein thrombosis.