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

NCT00862680 | Completed FDA Drug

• 3 other identifiers: 2008-0853NCI-2018-01858P30CA016672
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Maximum lesion standardized uptake value (SUVmax) for gated and ungated positron emission tomography/computed tomography (PET/CT) scans

  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

  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

Study Arms (1)

Diagnostic (4D PET/CT)

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

Procedure: 4-Dimensional Computed Tomography; Procedure: 4D PET Scan

Interventions

4-Dimensional Computed Tomography PROCEDURE

Undergo 4D PET/CT

Also known as: 4D Computed Tomography, 4DCT, Time-Resolved CT Data Acquisition

Diagnostic (4D PET/CT)

4D PET Scan PROCEDURE

Undergo 4D PET/CT scan

Also known as: 4D Gated PET, 4D Gated PET Scan, 4D PET

Diagnostic (4D PET/CT)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Colorectal Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Osama Mawlawi

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2009
• First Posted: March 17, 2009
• Study Start: March 12, 2009
• Primary Completion: April 28, 2019
• Study Completion: April 28, 2019
• Last Updated: April 14, 2020

Record last verified: 2020-04

Locations

US (1)