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Completed

NCT Number: NCT02489838

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

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

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Key information

Conditions

Liver Neoplasms Digestive System Diseases Digestive System Neoplasms Liver Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radiation Oncology, University of Rochester, Medical Center

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Alan Katz

Other

Registry information

Official study title

Analysis of Lung Dose Using Volumetric Analysis in Patients Treated With Yttrium-90 Microsphere Radioembolization for Hepatocellular Carcinoma

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Jul 3, 2015
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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