Lung Dose in Patients Treated With Yttrium-90 for Hepatoc... | NCT02489838

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

NCT02489838

Sponsor

Alan Katz

Status

Completed

Last Update Posted

Jun 11, 2020Actual

Enrollment

56Actual

Phase

Not provided

Conditions

Liver Neoplasms

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 3, 2012Actual

Primary Completion Date

Aug 7, 2019Actual

Completion Date

Aug 7, 2019Actual

First Submitted Date

Dec 24, 2014

First Submission Date that Met QC Criteria

Jul 1, 2015

First Posted Date

Jul 3, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2020

Last Update Posted Date

Jun 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Cancer Patients at the University of Rochester

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alan Katz, MD	Universtiy of Rochester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radiation Oncology, University of Rochester, Medical Center		Rochester	New York	14642	United States

Condition Browse Module

MeSH Terms

ID	Term
D008113	Liver Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided