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

Completed

• Conditions: Liver Neoplasms

• Registration Number: NCT02489838
• Lead Sponsor: Alan Katz

Brief Summary

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 Timeline

• Study Start: 2012-02-03
• Study First Submitted: 2014-12-24
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-03
• Primary Completion: 2019-08-07
• Study Completion: 2019-08-07
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-10
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lung dose measured with actual lung mass vs Lung dose measured with conventional method.	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.

Trial Locations

Locations (1)

Radiation Oncology, University of Rochester, Medical Center; 🇺🇸 Rochester, New York, United States