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Volumetric Analysis in the Assessment of Therapy Response by CT

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ClinicalTrials.gov Identifier: NCT00582751
Recruitment Status : Completed
First Posted : December 28, 2007
Last Update Posted : November 2, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
To compare the volumetric response achieved using semi-automated computer techniques with the uni-dimensional (RECIST) and bi-dimensional (WHO) criteria as part of clinical trials running at MSKCC, testing new agents for different types of solid tumors.

Condition or disease
Multiple Diseases

Detailed Description:
To compare the volumetric response achieved using semi-automated computer techniques with the uni-dimensional (RECIST) and bi-dimensional (WHO) criteria as part of clinical trials running at MSKCC, testing new agents for different types of solid tumors.

Study Design

Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Volumetric Analysis in the Assessment of Therapy Response by CT
Study Start Date : November 2007
Primary Completion Date : November 2010
Study Completion Date : November 2010
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. To compare volumetric response achieved using semi-automated computer techniques with the uni-dimensional (RECIST) and bi-dimensional (WHO) criteria as part of clinical trials running at MSKCC, testing new agents for different types of solid tumors. [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
90 patients from 3 different sections will be accrued (30 liver lesions, 30 lung lesions, 30 lymph node lesions).
Criteria

Inclusion Criteria:

  • Registered and being treated on one of the following therapeutic protocols:

06-043, 07-052, 07-057, 07-112, 07-116, 08-093, and 08-054

  • Have at least one measurable lesion* as per RECIST criteria situated in lung, liver or lymph node meeting RECIST criteria noted on a baseline CT scan.
  • Baseline** and at least one follow-up CT scan to likely to be obtained at an MSKCC facility
  • All patients must be > or = to 18 years old

    • The measurable lesions are metastatic in the liver, lung and lymph nodes. The algorithms do not distinguish between primary and metastatic disease, therefore, in selected cases, a primary lesion such as in the liver or lung may also be assessed.

      • Baseline CT are prefer but if not able to obtain for volumetric reconstructions follow up studies will still be use for other objectives if the study.

Exclusion Criteria:

  • Pregnant or lactating women
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582751


Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Robert Lefkowitz, MD Memorial Sloan Kettering Cancer Center
More Information

Additional Information:
Responsible Party: Robert Lefkowitz, MD, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00582751     History of Changes
Obsolete Identifiers: NCT00577291
Other Study ID Numbers: 07-141
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: November 2, 2010
Last Verified: November 2010

Keywords provided by Memorial Sloan Kettering Cancer Center:
Volumetric Analysis
Multiple Diseases