Liver NeoplasmsNCT02489838
Lung Dose in Patients Treated With Yttrium-90 for Hepatocellular Carcinoma
An observational study of Liver Neoplasms, run by Alan Katz at 1 site in United States.
Trial summary
To Calculate the amount radiation the lung receives in patients receiving Yttrium-90 for Liver Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasms
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2012to 7 Aug 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer Patients at the University of Rochester
Who may be able to join
- Adults ≥ 18 years with no upper limit.-Receiving Y-90 Therasphere liver directed therapy
- Pathology proven diagnosis of hepatocellular carcinoma, metastatic colon cancer or other metastatic diseases to be treated with SIRT (Y-90)
- surgical resection not feasible at time of initiation of pre-treatment workup
- -> 6 months projected life span
- ECOG 0-2
Who cannot join
- previous radioembolization of one or more liver lobes or segments without available treatment planning and procedural documentation ie. at another facility prior to URMC Y-90 radioembolization.
Trial locations and contacts
1 site in 1 country.
United States1 site
Radiation Oncology, University of Rochester, Medical Center
Rochester, New York, 14642
About this study
Official title: Analysis of Lung Dose Using Volumetric Analysis in Patients Treated With Yttrium-90 Microsphere Radioembolization for Hepatocellular Carcinoma
To Calculate the amount radiation the lung receives in patients receiving Yttrium-90 for Liver Cancer.
Read the detailed description
To calculate the delivered lung dose using quantitative volumetric analysis in a cohort of patients with unresectable hepatocellular carcinoma who undergo selective internal radiation therapy (SIRT) with Yttrium-90 glass microspheres (TheraSphere®)-and compare this analysis to the lung dose estimated by established criteria. In addition, this study, will summarize the pre and post-treatment clinical data to describe the URMC Y-90 experience.
- Conditions
- Liver Neoplasms
- Keywords
- Liver Neoplasma, Lung Radiation dose
- Medical subject headings
- Liver Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung dose measured with actual lung mass vs Lung dose measured with conventional method.
Lung dose measured with actual lung mass vs Lung dose measured with conventional method which assumes 1 kg for all patients.
Patient will be receiving this treatment even if not enrolled on this study.
The study is NOT about the intervention given to the patient. The study is to determine the best way to measure the radiation dose normal tissue (the lung specifically) receives during this standard treatment.
Measured: 1 month after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study start3 Feb 2012
- Primary completion7 Aug 2019
- Study completion7 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alan Katz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alan Katz, University of Rochester
- Investigators
- Alan Katz, MD, Principal investigator, Universtiy of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489838
- Sponsor's protocol ID
- ULAB11069
- Status last verified
- Jun 2020
- First submitted
- 24 Dec 2014
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Lung Dose Using Volumetric Analysis in Patients Treated With Yttrium-90 Microsphere Radioembolization for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02489838
- Acronym / sponsor ID
- ULAB11069
- Conditions
- Liver Neoplasms
- Keywords
- Liver Neoplasma, Lung Radiation dose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Alan KatzUniversity, hospital or other
- Study start
- 3 Feb 2012 (actual)
- Primary completion
- 7 Aug 2019 (actual)
- Study completion
- 7 Aug 2019 (actual)
- First posted
- 3 Jul 2015 (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.
To Calculate the amount radiation the lung receives in patients receiving Yttrium-90 for Liver Cancer.
Detailed description
To calculate the delivered lung dose using quantitative volumetric analysis in a cohort of patients with unresectable hepatocellular carcinoma who undergo selective internal radiation therapy (SIRT) with Yttrium-90 glass microspheres (TheraSphere®)-and compare this analysis to the lung dose estimated by established criteria. In addition, this study, will summarize the pre and post-treatment clinical data to describe the URMC Y-90 experience.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer Patients at the University of Rochester
Key inclusion criteria (5 listed)
- Adults ≥ 18 years with no upper limit.-Receiving Y-90 Therasphere liver directed therapy
- Pathology proven diagnosis of hepatocellular carcinoma, metastatic colon cancer or other metastatic diseases to be treated with SIRT (Y-90)
- surgical resection not feasible at time of initiation of pre-treatment workup
- -> 6 months projected life span
- ECOG 0-2
Key exclusion criteria (1 listed)
- previous radioembolization of one or more liver lobes or segments without available treatment planning and procedural documentation ie. at another facility prior to URMC Y-90 radioembolization.
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
Lung dose measured with actual lung mass vs Lung dose measured with conventional method.
Time frame: 1 month after treatment.
Lung dose measured with actual lung mass vs Lung dose measured with conventional method which assumes 1 kg for all patients. Patient will be receiving this treatment even if not enrolled on this study. The study is NOT about the intervention given to the patient. The study is to determine the best way to measure the radiation dose normal tissue (the lung specifically) receives during this standard treatment.
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 11 Jun 2020.
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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.
Alan Katz, MD principal investigator
Universtiy of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Neoplasms, run by Alan Katz at 1 site in United States.
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 5 inclusion and 1 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 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Lung dose measured with actual lung mass vs Lung dose measured with conventional method. (time frame: 1 month after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2020.