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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014