Computer Assisted Volumetric Analysis of CT-Identified Metastatic Pulmonary Or Hepatic Lesions
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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 |
- 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.
- 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) |
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 |
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| United States, Massachusetts | |
| Lahey Clinic, Inc. | |
| Burlington, Massachusetts, United States, 01805 | |
| 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 May 19, 2013