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

This study has been terminated.

(Low participant enrollment, Insufficient findings for data analysis)

Sponsor:

Information provided by (Responsible Party):

Lahey Clinic

ClinicalTrials.gov Identifier:

NCT00676455

First received: May 8, 2008

Last updated: May 9, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 8, 2008

Last Updated Date

May 9, 2013

Start Date ^ICMJE

February 2007

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

This Study Assessed the Ability of MeVis™ Volumetry Software to Reproducibly Measure the Changes in Metastatic Hepatic and Pulmonary Lesions [ Time Frame: As long as treatment is being assessed by CT examinations ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

This study will evaluate the ability of MeVis™ volumetry software to reproducibly measure the changes in metastatic hepatic and pulmonary lesions [ Time Frame: prospective ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00676455 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Tumor Size Will be Measured by CT (by the MeVis Volumetry Software and Correlated With On-going Treatment Plan. [ Time Frame: As long as treatment is being assessed by CT examinations ] [ Designated as safety issue: No ]

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.

Original Secondary Outcome Measures ^ICMJE

To correlate the tumor growth with clinical treatment conditions [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Subjects to be recruited from the practice of the Oncology Department. All subjects with hepatic or pulmonary metastatic lesions will be offered the opportunity to participate

Condition ^ICMJE

Metastatic Cancer

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

January 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00676455

Other Study ID Numbers ^ICMJE

2007-017

Has Data Monitoring Committee

Responsible Party

Lahey Clinic

Study Sponsor ^ICMJE

Lahey Clinic

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Christoph Wald, M.D., Ph.D

Lahey Clinic, Inc.

Information Provided By

Lahey Clinic

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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