Lung Dose in Patients Treated With Yttrium-90 for Hepatocellular Carcinoma

NCT ID: NCT02489838

Last Updated: 2020-06-11

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

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-03

Study Completion Date

2019-08-07

Brief Summary

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To Calculate the amount radiation the lung receives in patients receiving Yttrium-90 for Liver Cancer.

Detailed Description

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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

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Liver Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alan Katz

OTHER

Sponsor Role lead

Responsible Party

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Alan Katz

Associate Professor, Radiation Oncology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Alan Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Universtiy of Rochester

Locations

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Radiation Oncology, University of Rochester, Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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ULAB11069

Identifier Type: -

Identifier Source: org_study_id

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