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Low participant enrollment, Insufficient findings for data analysis
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Wald, M.D., Ph.D | Lahey Clinic, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lahey Clinic, Inc. | Burlington | Massachusetts | 01805 | United States |
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Approximately 100 participants were to be enrolled, with approximately 50 of each type of metastatic disease. 50 participants with metastatic Liver tumors and 50 with metastatic Lung tumors.
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| ID | Title | Description |
|---|---|---|
| FG000 | Metastatic Lung and Liver Tumor Growth Measurement | This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Metastatic Lung and Liver Tumor Growth Measurement | This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Due to low enrollment no analysis was conducted due to the lack of participants. | Posted | Aug 2009 | As long as treatment is being assessed by CT examinations |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metastatic Lung and Liver Tumor Growth Measurement | This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Wald, MD | Lahey Clinic | 781-744-8710 | Christopher.Wald@lahey.org |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| As long as treatment is being assessed by CT examinations |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
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| Participants |
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| Secondary | 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. | Due to low enrollment no analysis was conducted due to the lack of participants. | Posted | Aug 2009 | As long as treatment is being assessed by CT examinations |
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| 0 |
| 14 |
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| 14 |
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