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

Carcinoma, Hepatocellular Clinical Trial

— PET-Y90  

Official title:

Pair Production PET Imaging to Detect Particle Distribution in Patients Undergoing Yttrium-90 Radioembolization With Large Hepatocellular Carcinomas or Associated Portal Vein Thrombosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02848638
• Other study ID #: 42413
• Status: Completed
• Start date: July 2012
• Est. completion date: March 31, 2018

Study information

• Verified date: July 2018
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 31, 2018
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree and distribution of Y90 particle uptake	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.	Within one year of Enrollment completion