Computer Assisted Volumetric Analysis of CT-Identified Metastatic Pulmonary Or Hepatic Lesions

Terminated

• Conditions: Metastatic Cancer

• Registration Number: NCT00676455
• Lead Sponsor: Lahey Clinic

Brief Summary

The purpose of this study is to evaluate the ability of a new type of CT computer program(MeVis™)to accurately analyze and measure the size and changes in metastatic Liver and Lung tumors. This study will evaluate the data from current CT evaluation methods using the MeVis™ 3-D software.

Detailed Description

This is a Pilot Study that will evaluate if metastatic liver and lung tumor measurements made by the MeVis™ software program can provide more accurate information about the size and changes of the tumor compared to the current evaluation method, RECIST(Response Evaluation In Solid Tumors). This study will also collect information about the kind of treatment each subject receives.

Subjects will receive standard of care surveillance CT examinations(a baseline to document tumor size and interval CT exams as indicated by the Oncology Department Protocols); the tumor will be measured according to the current standard-RECIST by Radiology personnel not involved in the study. The CT data will then be analyzed by investigators using the MeVis™ software.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2008-05-08
• Study First Submitted QC: 2008-05-12
• Study First Posted: 2008-05-13
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Results First Submitted: 2009-08-26
• Results First Submitted QC: 2011-06-30
• Results First Posted: 2011-07-29
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-09
• Last Update Posted: 2013-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Subjects with cancer metastatic to either the liver or lungs
• Subjects Scheduled for regular CT surveillance examinations
• Subjects with life expectancy of at least 6 months

Exclusion Criteria

• Age <18 years
• No written informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This Study Assessed the Ability of MeVis™ Volumetry Software to Reproducibly Measure the Changes in Metastatic Hepatic and Pulmonary Lesions	As long as treatment is being assessed by CT examinations	Due to the low enrollment for this project the data collected is not sufficient to provide any significant conclusion to the primary outcome hypothesis.; Due to lack of participants. No significant findings are reported at this time.

Secondary Outcome Measures

Name	Time	Method
Tumor Size Will be Measured by CT (by the MeVis Volumetry Software and Correlated With On-going Treatment Plan.	As long as treatment is being assessed by CT examinations	Tumor size will be measured by CT (by the MeVis Volumetry Software and correlated with on-going treatment plan.; Correlation of the tumor growth with clinical treatment will be assessed. Tumor size will be expressed in volume. Specifically Three dimensional volume Volume of Interest(VOI)will be calculated and correlated with the treatment protocol. Measure = tumor volume.

Trial Locations

Locations (1)

Lahey Clinic, Inc.; 🇺🇸 Burlington, Massachusetts, United States