Clinical trial NCT01052766: Breathing Synchronized PET/CT Scans for the Detection of Malignant Lung & Liver Lesions and Assessment of Tumor Glycolysis
Official title: The Use of Breathing Synchronized PET/CT Scans for the Detection of Malignant Lung and Liver Lesions and Assessment of Tumor Glycolysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Non-small Cell Lung Cancer
Keywords: lung cancer
PET Scan
CT Scan
BH-PET scan
09-134
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2010-01-20
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Patients with early stage biopsy-proven lung cancer or patients with lung or liver metastases from any primary cancer (metastatic disease proven by biopsy, or clearly established clinically and by imaging studies who are being treated with stereotactic body radiotherapy (SBRT)or an ablation will be eligible.
* Patient has at least one lesion ≥ 1cm in size.
* Signed informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Heiko Schoder, MD
role: PRINCIPAL_INVESTIGATOR
References: