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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)
ClinicalTrials.gov Identifier:
First Posted: May 13, 2008
Last Update Posted: May 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lahey Clinic
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.

Metastatic Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Computer Assisted Volumetric Analysis of CT-Identified Metastatic Pulmonary Or Hepatic Lesions

Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • 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 ]

    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:
  • 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 ]

    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.

Enrollment: 14
Study Start Date: February 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676455

United States, Massachusetts
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Principal Investigator: Christoph Wald, M.D., Ph.D Lahey Clinic, Inc.
  More Information

Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00676455     History of Changes
Other Study ID Numbers: 2007-017
First Submitted: May 8, 2008
First Posted: May 13, 2008
Results First Submitted: August 26, 2009
Results First Posted: July 29, 2011
Last Update Posted: May 10, 2013
Last Verified: May 2013

Keywords provided by Lahey Clinic:
CT Software
Metastatic pulmonary and hepatic lesion growth

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes