NCT00676455

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

July 29, 2011

Completed
Last Updated

May 10, 2013

Status Verified

May 1, 2013

Enrollment Period

1.9 years

First QC Date

May 8, 2008

Results QC Date

August 26, 2009

Last Update Submit

May 9, 2013

Conditions

Keywords

CT SoftwareMeVis™Metastatic pulmonary and hepatic lesion growth

Outcome Measures

Primary Outcomes (1)

  • This Study Assessed the Ability of MeVis™ Volumetry Software to Reproducibly Measure the Changes in Metastatic Hepatic and Pulmonary Lesions

    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.

    As long as treatment is being assessed by CT examinations

Secondary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Age \<18 years
  • No written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahey Clinic, Inc.

Burlington, Massachusetts, 01805, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Christopher Wald, MD
Organization
Lahey Clinic

Study Officials

  • Christoph Wald, M.D., Ph.D

    Lahey Clinic, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2008

First Posted

May 13, 2008

Study Start

February 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

May 10, 2013

Results First Posted

July 29, 2011

Record last verified: 2013-05

Locations