- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00676455
Computer Assisted Volumetric Analysis of CT-Identified Metastatic Pulmonary Or Hepatic Lesions
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Massachusetts
-
Burlington, Massachusetts, Förenta staterna, 01805
- Lahey Clinic, Inc.
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
This Study Assessed the Ability of MeVis™ Volumetry Software to Reproducibly Measure the Changes in Metastatic Hepatic and Pulmonary Lesions
Tidsram: 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. |
As long as treatment is being assessed by CT examinations
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Tumor Size Will be Measured by CT (by the MeVis Volumetry Software and Correlated With On-going Treatment Plan.
Tidsram: 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. |
As long as treatment is being assessed by CT examinations
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Christoph Wald, M.D., Ph.D, Lahey Clinic, Inc.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2007-017
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