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Assessing Response to Treatment in Patients With Solid Tumors
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00577291
  Purpose

RATIONALE: Diagnostic procedures, such as CT scans, may help measure solid tumors and assess a patient's response to treatment.

PURPOSE: This clinical trial is comparing two methods of measuring tumors by CT scan in patients with solid tumors.


Condition Intervention
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: computed tomography

MedlinePlus related topics: CT Scans Cancer Nuclear Scans
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Open Label
Official Title: Volumetric Analysis in the Assessment of Therapy Response by CT

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Volumetric response achieved using semi-automated computer techniques [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of CT scan slice thickness on size measurement [ Designated as safety issue: No ]
  • Variability (reproducibility) of 3 segmentation algorithms [ Designated as safety issue: No ]
  • Comparison of computer algorithm variability against intra- and inter-radiologist variability [ Designated as safety issue: No ]
  • Validation of each algorithm's accuracy by comparing measurements obtained form the computer algorithm with the "Gold Standard" radiologist reading [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: November 2007
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • To assess the effect of CT slice thickness on 3D, 2D, and 1D size measurements.
  • To study variability (reproducibility) of the three segmentation algorithms developed for liver, lung, and metastatic lymphadenopathy.
  • To compare computer algorithm variability against intra- and inter-radiologist variability.
  • To validate each algorithm's accuracy by comparing measurements obtained from the computer algorithm with the "Gold Standard" radiologist reading.

OUTLINE: The research project coordinator (RPC) is notified when a patient is scheduled for CT scan. The RPC forwards this information to the CT scan technician performing the CT scan on the patient per the therapeutic protocol. CT images of the patient reconstructed at different slice thicknesses are electronically transferred from the hospital PACS to the research PACS server where patient identification information is de-identified. The images stored in the research PACS are accessed by the research workstations where image processing and analysis is performed.

Segmentation algorithms are used to segment tumors, measure tumor sizes, and size changes in the course of chemotherapy. The variability of the algorithm and effects of CT image slice thickness on the size measurements is also studied.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Registered and being treated on 1 of the following therapeutic protocols:

    • MSKCC-06-043
    • MSKCC-07-052
    • MSKCC-07-057
  • Must have at least 1 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 1 follow-up CT scan obtained at an MSKCC facility NOTE: *The measurable lesion is metastatic in the liver, lung, or lymph node and algorithms do not distinguish between primary and metastatic disease, therefore, a primary lesion (e.g., in the liver or lung) may also be assessed

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577291

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Binsheng Zhao, DSc     212-639-8759        
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Binsheng Zhao, DSc Memorial Sloan-Kettering Cancer Center
Principal Investigator: Lawrence H. Schwartz, MD Memorial Sloan-Kettering Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000579023, MSKCC-07141
Study First Received: December 19, 2007
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00577291  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on January 16, 2009