Metastatic CancerNCT00676455
Computer Assisted Volumetric Analysis of CT-Identified Metastatic Pulmonary Or Hepatic Lesions
An observational study of Metastatic Cancer, run by Lahey Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jan 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Age <18 years
- No written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Metastatic Cancer
- Keywords
- CT Software, MeVis™, Metastatic pulmonary and hepatic lesion growth
- Medical subject headings
- Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: As long as treatment is being assessed by CT examinations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startFeb 2007
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Low participant enrollment, Insufficient findings for data analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Wald, M.D., Ph.D, Principal investigator, Lahey Clinic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676455
- Sponsor's protocol ID
- 2007-017
- Status last verified
- May 2013
- First submitted
- 8 May 2008
- Last updated
- 10 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Assisted Volumetric Analysis of CT-Identified Metastatic Pulmonary Or Hepatic Lesions
- ClinicalTrials.gov ID
- NCT00676455
- Acronym / sponsor ID
- 2007-017
- Conditions
- Metastatic Cancer
- Keywords
- CT Software, MeVis™, Metastatic pulmonary and hepatic lesion growth
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low participant enrollment, Insufficient findings for data analysis
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 13 May 2008 (estimated)
- Results
- Posted 29 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Age <18 years
- No written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Wald, M.D., Ph.D principal investigator
Lahey Clinic, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Cancer, run by Lahey Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2013.