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

NCT ID: NCT02848638

Last Updated: 2018-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2018-03-31

Brief Summary

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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

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Conditions

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Carcinoma, Hepatocellular

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Siddharth A. Padia

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Chan KT, Alessio AM, Johnson GE, Vaidya S, Kwan SW, Monsky W, Wilson AE, Lewis DH, Padia SA. Hepatotoxic Dose Thresholds by Positron-Emission Tomography After Yttrium-90 Radioembolization of Liver Tumors: A Prospective Single-Arm Observational Study. Cardiovasc Intervent Radiol. 2018 Sep;41(9):1363-1372. doi: 10.1007/s00270-018-1949-5. Epub 2018 Apr 12.

Reference Type DERIVED
PMID: 29651580 (View on PubMed)

Other Identifiers

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42413

Identifier Type: -

Identifier Source: org_study_id

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