The Use of Breathing Synchronized PET/CT Imaging In the Detection and Quantification of FDG Uptake in Lung Nodules

NCT00598065 | Completed DMC

• 1 other identifier: 04-025
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if researchers can improve the detection of lung cancer by using a new method which will help us to take multiple snapshot images of the lungs while the patient is breathing. We are also investigating whether with the help of this new method we can better measure the actual amount of radioactivity that is taken up by the cancer. The name of this new method is respiratory gated PET/CT. Previous research has shown that PET scans may be useful in investigating whether cancer has spread to other parts of the lung or body. Using our standard method, smaller cancers are sometimes difficult to detect in the lungs because the PET images are taken over several minutes and the patient is breathing during that time. That means the cancer may appear "blurred" on the images (like a poor photograph) or may not be identified at all. In this study, in addition to the images that were ordered by your doctor, we will take additional images of your lungs while you are following a breathing command ("breath in-hold-breath out"). We will then compare the images of your cancer during the regular PET study with those taken during the breathing commands. The hypotheses to be tested in this pilot study are:

1. 1.Respiratory gated image acquisition reduces partial volume effects on PET image that may render lung lesions undetectable.
2. 2.Breath-hold CT may detect small lung lesions that are beyond the limit of detection in shallow-breathing CT scans, related to respiratory motion which causes blurring artifacts around smaller lung lesions.

Conditions

Lung Cancer

Keywords

lung

Outcome Measures

Primary Outcomes (1)

• Pts w/suspected lung lesions will undergo more breath-hold CT scan & if visible lesion(s), gated-PET will be acquired plus clinical PET/CT. Scans will be used to compare how often additional lung lesions can be identified on breath-hold CT, if lesions

  5 years

Interventions

PET/CT OTHER

Synchronized PET/CT Imaging

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old
• Patients must have at least one lung lesion or lung cancer on prior chest Xray or chest CT.
• Sign informed consent. Eligible patients should give their consent at the beginning of the clinical PET scan. Following clinical CT and PET scans, breathhold CT should follow. Then, these breath-hold CT images will be reviewed by one of the investigating physicians to determine if the patient qualifies for the study. If there is a small lesion (\< 5 mm) gated PET images will be acquired.

You may not qualify if:

• Pregnant women are ineligible.
• Patients who are unable to follow breathing instructions either due to language difficulties or hearing impairment This will be determined by one of the consenting individuals when they approach the patient to ask for informed consent.
• Patients who are too ill to hold their breath.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Heiko Schoder, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 18, 2008
• Study Start: March 1, 2004
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 3, 2009

Record last verified: 2009-12

Locations

US (1)