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Benefits Study of Respiratory-gated PET Acquisition in Lung Disease (PneumoTEP)

Primary Purpose

Lung Cancer, Non Small Cell Lung Cancer, Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
medical imaging
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring PET/CT, 18F-fluoro-2-deoxyglucose, lung neoplasms, respiratory motion

Eligibility Criteria

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

Inclusion Criteria:

  • patient has one or more lung lesion(s) less than 35 mm visible on a CT image
  • age : over 18 years
  • patients gave their written informed consent

Exclusion Criteria:

  • pregnancy
  • patient has at least one lesion more than 35 mm in its great axis

Sites / Locations

  • CHU Amiens

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lung nodules

Arm Description

"Medical imaging" intervention applied on patients included in the trial

Outcomes

Primary Outcome Measures

Lesion SUVmax
For each CT nodule, observer has to report the corresponding (maximum Standardized Uptake Value)SUVmax on ungated and CT-based images (even if there is no obvious uptake)

Secondary Outcome Measures

Lung function test
Patients undergo lung function test including measures of: total lung capacity residual volume forced expiratory volume forced vital capacity

Full Information

First Posted
March 13, 2013
Last Updated
February 26, 2015
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT01812031
Brief Title
Benefits Study of Respiratory-gated PET Acquisition in Lung Disease
Acronym
PneumoTEP
Official Title
Benefits Study of a Respiratory Gating Protocol for Positron Emission Tomography: Application on the Lungs
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Fluorodeoxyglucose (FDG) positron emission tomography (PET) is now widely used for cancer imaging purpose, notably for preoperative work-up. It aims at visualizing organs metabolism. In case of cancer, metabolism is, classically, increased and some hot spots are visible on PET images. Because of respiratory motion some lung tumours (especially the smallest ones) can be falsely interpreted by the clinician. The investigators developed a respiratory-gated PET method in order to reduce the motion issue. The investigators designed a study to investigate its effect on lung cancer (primary or metastasis) to check if it improves the sensitivity/specificity of PET imaging of the lungs. To that aim, patients presenting a lung nodule on a CT examination can be proposed to participate this study. After the standard PET acquisition (acquired in free-breathing), an additional 10 minutes respiratory-gated PET acquisition is performed without additional injection. After that, a breath-hold (~10s) CT is performed.

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, Chronic Obstructive Pulmonary Disease
Keywords
PET/CT, 18F-fluoro-2-deoxyglucose, lung neoplasms, respiratory motion

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lung nodules
Arm Type
Experimental
Arm Description
"Medical imaging" intervention applied on patients included in the trial
Intervention Type
Other
Intervention Name(s)
medical imaging
Other Intervention Name(s)
Biograph, Siemens medical solutions, Anzai medical
Intervention Description
After fasting for at least 6 hours, normal glucose blood level was checked and each patient received an intravenous injection of 18F-FDG (5MBq/kg). After a 60-minute uptake phase in a quiet environment, patients underwent the PET/CT examination. Whole-body PET/CT (Ungated session) The Ungated acquisition consisted in a whole-body, free-breathing CT followed by standard multistep PET, used as routine clinical practice in the department. Respiratory-gated PET/CT (CT-based session) The CT-based method consisted in an additional single-step, 10-minute List Mode respiratory gated PET acquisition followed by an end-expiration breath-hold CT added to the end of the clinical protocol, with continuous respiratory signal recording during these examinations.
Primary Outcome Measure Information:
Title
Lesion SUVmax
Description
For each CT nodule, observer has to report the corresponding (maximum Standardized Uptake Value)SUVmax on ungated and CT-based images (even if there is no obvious uptake)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Lung function test
Description
Patients undergo lung function test including measures of: total lung capacity residual volume forced expiratory volume forced vital capacity
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient has one or more lung lesion(s) less than 35 mm visible on a CT image age : over 18 years patients gave their written informed consent Exclusion Criteria: pregnancy patient has at least one lesion more than 35 mm in its great axis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc-Etienne MEYER, MD, PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21511870
Citation
Daouk J, Leloire M, Fin L, Bailly P, Morvan J, El Esper I, Saidi L, Moullart V, Francois G, Jounieaux V, Meyer ME. Respiratory-gated 18F-FDG PET imaging in lung cancer: effects on sensitivity and specificity. Acta Radiol. 2011 Jul 1;52(6):651-7. doi: 10.1258/ar.2011.110018. Epub 2011 Apr 21.
Results Reference
result
PubMed Identifier
25567204
Citation
Daouk J, Bailly P, Kamimura M, Sacksick D, Jounieaux V, Meyer ME. Positron emission tomography-based evidence of low-amplitude respiratory motion in patients with chronic obstructive pulmonary disease. Ann Nucl Med. 2015 May;29(4):319-24. doi: 10.1007/s12149-014-0945-3. Epub 2015 Jan 8.
Results Reference
result

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Benefits Study of Respiratory-gated PET Acquisition in Lung Disease

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