Metastatic Cancer
Conditions
Keywords
CT Software, MeVis™, Metastatic pulmonary and hepatic lesion growth
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.
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.
Interventions
None listed
Sponsors
Lahey Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| This Study Assessed the Ability of MeVis™ Volumetry Software to Reproducibly Measure the Changes in Metastatic Hepatic and Pulmonary Lesions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Metastatic Lung and Liver Tumor Growth Measurement |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
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.
Time frame: As long as treatment is being assessed by CT examinations
Population: Due to low enrollment no analysis was conducted due to the lack of participants.
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.
Time frame: As long as treatment is being assessed by CT examinations
Population: Due to low enrollment no analysis was conducted due to the lack of participants.