Volumetric Analysis in the Assessment of Therapy Response by CT

Multiple Diseases Clinical Trial

Official title:

Volumetric Analysis in the Assessment of Therapy Response by CT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582751
• Other study ID #: 07-141
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: November 1, 2010
• Start date: November 2007
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00577291

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Diseases

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

•   Memorial Sloan-Kettering Web Site