NCT02489838

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2012

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2019

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

7.5 years

First QC Date

December 24, 2014

Last Update Submit

June 10, 2020

Conditions

Liver Neoplasms

Keywords

Liver NeoplasmaLung Radiation dose

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer Patients at the University of Rochester

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiation Oncology, University of Rochester, Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • Alan Katz, MD

    Universtiy of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Radiation Oncology

Study Record Dates

First Submitted

December 24, 2014

First Posted

July 3, 2015

Study Start

February 3, 2012

Primary Completion

August 7, 2019

Study Completion

August 7, 2019

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations

US(1)