Carcinoma, HepatocellularPET-Y90NCT02848638
Pair Production PET Imaging to Detect Particle Distribution in Patients Undergoing Yttrium-90 Radioembolization
An observational study of Carcinoma, Hepatocellular, run by University of Washington.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to 31 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- UWMC patients over 18 years of age
- Presence of hepatocellular carcinoma greater than 5 cm OR presence of tumor-associated portal vein thrombosis.
- Currently undergoing treatment with Yttrium-90 Radioembolization
- Able to sign informed consent
Who cannot join
- Patients who are not undergoing treatment with Yttrium-90 Radioembolization
- Patients unable to provide informed consent
About this study
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
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.
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- PET, Yttrium-90
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within one year of Enrollment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJul 2012
- Primary completionMar 2016
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siddharth A. Padia, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848638
- Sponsor's protocol ID
- 42413
- Acronym
- PET-Y90
- Status last verified
- Jul 2018
- First submitted
- 26 Jul 2016
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29651580
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02848638
- Acronym / sponsor ID
- PET-Y90 / 42413
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- PET, Yttrium-90
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- UWMC patients over 18 years of age
- Presence of hepatocellular carcinoma greater than 5 cm OR presence of tumor-associated portal vein thrombosis.
- Currently undergoing treatment with Yttrium-90 Radioembolization
- Able to sign informed consent
Key exclusion criteria (2 listed)
- Patients who are not undergoing treatment with Yttrium-90 Radioembolization
- Patients unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Derived from this study: PubMed 29651580Chan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Hepatocellular, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree and distribution of Y90 particle uptake (time frame: Within one year of Enrollment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02848638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018; AzTrials last refreshed its copy on 6 Nov 2026.