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Trial record 56 of 483 for:    colon cancer | ( Map: Texas, United States )

4D PET/CT in Diagnosing Participants With Lung and Colorectal Cancer With Liver and Lung Metastasis

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ClinicalTrials.gov Identifier: NCT00862680
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This trial studies how well 4 dimensional (D) positron emission tomography/computed tomography (PET/CT) works in diagnosing participants with lung or colorectal cancer that has spread to the liver and lung. Diagnostic procedures, such as PET/CT, may help find and diagnose disease and find out how far the disease has spread. But the motions made by breathing can reduce the image quality of the scan. Adjusting the scanner to 4D may allow for more breathing motion may improve the quality of the PET/CT images.

Condition or disease Intervention/treatment Phase
Metastatic Malignant Neoplasm in the Liver Metastatic Malignant Neoplasm in the Lung Stage IV Colorectal Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8 Procedure: 4-Dimensional Computed Tomography Procedure: 4D PET Scan Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. Study the impact of 4D positron emission tomography/computed tomography (PET/CT) imaging on the evaluation and staging of lung and colorectal cancer.

OUTLINE:

Participants undergo 4D PET/CT scan over up to 12 minutes.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 4D PET/CT Imaging in Lung and Colorectal Cancer With Liver Metastasis
Actual Study Start Date : March 12, 2009
Actual Primary Completion Date : April 28, 2019
Actual Study Completion Date : April 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic (4D PET/CT)
Participants undergo 4D PET/CT scan over up to 12 minutes.
Procedure: 4-Dimensional Computed Tomography
Undergo 4D PET/CT
Other Names:
  • 4D Computed Tomography
  • 4DCT
  • Time-Resolved CT Data Acquisition

Procedure: 4D PET Scan
Undergo 4D PET/CT scan
Other Names:
  • 4D Gated PET
  • 4D Gated PET Scan
  • 4D PET




Primary Outcome Measures :
  1. Maximum lesion standardized uptake value (SUVmax) for gated and ungated positron emission tomography/computed tomography (PET/CT) scans [ Time Frame: Up to 10 years ]
    Will be compared using a one-sided paired t-test.

  2. Impact of the difference in SUVmax on the lesion detectability and staging of the evaluated patients [ Time Frame: Up to 10 years ]
    two nuclear medicine physicians will assess the impact of the difference in SUVmax on the lesion detectablility and staging of the evaluated patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with suspected colorectal cancer with nodules in the lung or liver (1-2 cm in diameter) will be eligible for this study.
  • Patients with suspected lung cancer with nodules in the lung or liver (1-2 cm in diameter) will be eligible for this study.

Exclusion Criteria:

  • Patients that cannot tolerate being scanned for an additional 12 minutes with arms above their head will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862680


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Osama Mawlawi Mawlawi M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00862680     History of Changes
Other Study ID Numbers: 2008-0853
NCI-2018-01858 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2008-0853 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Colorectal Neoplasms
Neoplasms, Second Primary
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Colonic Diseases
Lung Diseases
Respiratory Tract Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases