Volumetric Analysis in the Assessment of Therapy Response by CT

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00582751
First received: December 21, 2007
Last updated: November 1, 2010
Last verified: November 2010
  Purpose

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
Multiple Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Volumetric Analysis in the Assessment of Therapy Response by CT

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: November 2007
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: December 21, 2007
Last Updated: November 1, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 20, 2014