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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02848638

Acronym

PET-Y90

Enrollment

Registered

2016-07-28

Start date

2012-07-31

Completion date

2018-03-31

Last updated

2018-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Hepatocellular

Keywords

PET, Yttrium-90

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results