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

April 10, 2020 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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:
  • 4DCT
  • 4D Computed Tomography
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 10 years
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.
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Osama Mawlawi, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2009

Primary Completion (Actual)

April 28, 2019

Study Completion (Actual)

April 28, 2019

Study Registration Dates

First Submitted

March 16, 2009

First Submitted That Met QC Criteria

March 16, 2009

First Posted (Estimate)

March 17, 2009

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 10, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-0853 (Other Identifier: M D Anderson Cancer Center)
  • P30CA016672 (U.S. NIH Grant/Contract)
  • NCI-2018-01858 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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