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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01052766
Other study ID # 09-134
Secondary ID
Status Terminated
Phase N/A
First received January 18, 2010
Last updated March 15, 2012
Start date January 2010
Est. completion date March 2012

Study information

Verified date March 2012
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 11
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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.

Locations

Country Name City State
United States Memorial Sloan-Kettering Cancer Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 years No
Secondary 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. 2 years No
Secondary 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. 2 years No
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