Breathing Synchronized PET/CT Scans for the Detection of Malignant Lung & Liver Lesions and Assessment of Tumor Glycolysis
In this particular study the physicians want to use a new technique of how they obtain the PET/CT pictures. It is called breath-hold (BH) PET/CT". As the name suggests, they will ask the patient to hold their breath for about 20-30 seconds, and only during that time will they obtain pictures. This is repeated several times. In contrast to the standard PET/CT scan, they expect less "blurring" of the pictures, so that they can see the tumor better and measure the uptake of radioactive sugar in the tumor better and more reliably. Basically, this is the difference between taking pictures of a runner as compared to taking pictures of a person standing still. Since PET images need to be obtained over several minutes and people can not hold their breath for this extended time, we break the procedure into several cycles of 20-30 seconds (or longer, if possible) and then add all the "frozen" pictures in the end into one. They want to know if BH PET/CT scan measure changes in the cancer during therapy (i.e., from the baseline scan before therapy to the follow up scan at within 4 weeks later).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Use of Breathing Synchronized PET/CT Scans for the Detection of Malignant Lung and Liver Lesions and Assessment of Tumor Glycolysis|
- To investigate whether BH-PET scan improves detectability of the lung & liver lesions seen on breath-hold CT scans as compared to their detectability on standard clinical PET scan. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To compare the magnitude of changes in SUV between pre and post therapy pet scans done as either standard clinical PET/CT or BH PET/CT. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To investigate whether the correlation between change in SUV and the lesion response on follow-up scan (3 months) is different for standard clinical PET/CT versus BH scan. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Experimental: PET/CT and BH PET/CT
In collaboration with the Department of Radiation Oncology and the Interventional Radiology Service, patients with lung or liver cancer or lung or liver metastases in whom FDG PET/CT is part of the clinical standard of care for disease evaluation and response assessment will be enrolled in this study. We will perform a clinical PET/CT and BH PET/CT (for two bed positions covering the entire chest) prior to, and again 1-2 weeks after SBRT or RFA. This early time point is chosen because a few weeks after the completion of treatment, acute radiation injury in the lung begins and will likely be detectable as abnormal uptake on follow-up PET imaging making it difficult to assess tumor recurrence.
Procedure: PET/CT and BH PET/CT
First, fiducial markers will be placed and taped on the patient's lower chest/upper abdomen. This will allow for monitoring of chest motion during breathing. A BH-CT scan will then be acquired with clinical CT scan parameters used in nuclear medicine. A BH-PET scan (acquisition time: 6 min per bed position) will follow the BH-CT scan. BH-PET images will cover the whole thorax, which, on average, corresponds to 1-3 PET FOV's (~15 cm/FOV). Data for these 1-3 bed positions are acquired to cover the entire thorax. There will be no additional radiotracer injection for the BH-PET scan.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052766
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Heiko Schoder, MD||Memorial Sloan Kettering Cancer Center|