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
  Purpose

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.


Condition
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

Resource links provided by NLM:


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 ] [ 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.



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 ] [ 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.



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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676455

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

No publications provided

Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00676455     History of Changes
Other Study ID Numbers: 2007-017
Study First Received: May 8, 2008
Results First Received: August 26, 2009
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014