Volumetric Analysis in the Assessment of Therapy Response by CT

NCT00582751 | Completed

• 1 other identifier: 07-141
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Diseases

Keywords

Volumetric Analysis; Multiple Diseases

Outcome Measures

Primary Outcomes (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.

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• Pregnant or lactating women

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Web Site

Study Officials

• Robert Lefkowitz, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 28, 2007
• Study Start: November 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 2, 2010

Record last verified: 2010-11

Locations

US (1)