4D PET/CT Imaging in Lung and Colorectal Cancer With Liver Metastasis - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center GE Healthcare
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00862680

Purpose

The objective of this proposal is to study the impact of 4D Positron Emission Tomography/Computed Tomography (PET/CT) imaging on the evaluation and staging of lung and colorectal cancer.

This research project has three goals:

Acquire 4D PET/CT data on 26 lung and/or colorectal patients with specific inclusion criteria.
Compare lesion SUVmax between gated and non-gated PET scans.
Evaluate the impact of the difference in the maximum standardized uptake value (SUVmax) on lesion detectability and staging.

Condition	Intervention
Colorectal Cancer Lung Cancer Liver Cancer	Procedure: PET/CT Scan

MedlinePlus related topics: CT Scans Cancer Colorectal Cancer Liver Cancer Lung Cancer Nuclear Scans

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	4D PET/CT Imaging in Lung and Colorectal Cancer With Liver Metastasis

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Learn if adjusting the PET/CT scanner to allow for breathing motion can improve the quality of PET/CT images. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	26
Study Start Date:	March 2009
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental PET/CT Scan	Procedure: PET/CT Scan Routine PET/CT scan with small plastic box (weighing less than 1 oz) placed on abdominal area to track breathing motion.

Detailed Description:

Routine PET/CT scans are taken while patients are breathing normally. The motions made by breathing can reduce the image quality of the scan.

Minimizing the effects of this motion by taking the images and processing the scans differently may improve the image quality.

The PET/CT Scan:

If you agree to take part in this study, a small plastic box (weighing less than 1 ounce) will be placed on your abdominal area before your routine PET/CT scan. This box is used to track your breathing motion. This information will be used to help process the scan.

Your PET/CT scan will be performed as usual. During the scan, the researchers will focus on your lower chest/upper abdomen (areas that experience breathing motion). Having to focus on this area might extend the scan by up to 12 minutes.

Length of Study:

Your participation on this study will be complete when your scheduled PET/CT scan is complete.

This is an investigational study. The imaging focused on your lower chest/upper abdomen during the scan is investigational.

Up to 26 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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:

Pediatric patients (younger than 18 years) will be excluded.
Patients that cannot tolerate being scanned for an additional 12 minutes with arms above their head will be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862680

Contacts

Contact: Osama R. Mawlawi, PhD

713-563-2711

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Osama R. Mawlawi, PhD

Sponsors and Collaborators

M.D. Anderson Cancer Center

GE Healthcare

Investigators

Principal Investigator:

Osama R. Mawlawi, PhD

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UT MD Anderson Cancer Center ( Osama R. Mawlawi, PhD / Associate Professor )
Study ID Numbers:	2008-0853
Study First Received:	March 16, 2009
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00862680 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Lung Colorectum
Colorectal cancer
Lung Cancer
Liver Cancer
Non-small cell lung cancer

NSCLC
4D PET/CT Imaging
Positron emission tomography/computed tomography
PET/CT scan
Breathing motion

Study placed in the following topic categories:

Thoracic Neoplasms
Liver Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Liver Neoplasms

Digestive System Diseases
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasm Metastasis
Non-small Cell Lung Cancer
Gastrointestinal Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Liver Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Liver Neoplasms
Neoplastic Processes

Neoplasms
Pathologic Processes
Neoplasms by Site
Digestive System Diseases
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009