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Breathing Synchronized PET/CT Scans for the Detection of Malignant Lung & Liver Lesions and Assessment of Tumor Glycolysis

Primary Purpose

Lung Cancer, Non-small Cell Lung Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET/CT and BH PET/CT
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring lung cancer, PET Scan, CT Scan, BH-PET scan, 09-134

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET/CT and BH PET/CT

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 18, 2010
Last Updated
March 15, 2012
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT01052766
Brief Title
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

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Lack of accrual
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
GE Healthcare

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Non-small Cell Lung Cancer
Keywords
lung cancer, PET Scan, CT Scan, BH-PET scan, 09-134

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PET/CT and BH PET/CT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
PET/CT and BH PET/CT
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heiko Schoder, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan-Kettering Cancer Center

Learn more about this trial

Breathing Synchronized PET/CT Scans for the Detection of Malignant Lung & Liver Lesions and Assessment of Tumor Glycolysis

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