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

Liver Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02489838
• Other study ID #: ULAB11069
• Status: Completed
• Start date: February 3, 2012
• Est. completion date: August 7, 2019

Study information

• Verified date: June 2020
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 7, 2019
• Est. primary completion date: August 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Neoplasms

Locations

Country	Name	City	State
United States	Radiation Oncology, University of Rochester, Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Alan Katz

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month after treatment.