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Pair Production PET Imaging to Detect Particle Distribution in Patients Undergoing Yttrium-90 Radioembolization (PET-Y90)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02848638
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Siddharth A. Padia, 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.


Condition or disease
Carcinoma, Hepatocellular

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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : July 2012
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Yttrium




Primary Outcome Measures :
  1. Degree and distribution of Y90 particle uptake [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients (18-85 years old), who have hepatocellular carcinoma with tumors that are greater than 5 cm or have tumor-associated portal vein thrombosis. The patients are currently undergoing treatment with Yttrium-90 Radioembolization, as part of their clinical care.
Criteria

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Siddharth A. Padia, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT02848638    
Other Study ID Numbers: 42413
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Siddharth A. Padia, University of Washington:
PET, Yttrium-90
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases