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Clinical Trials/NCT01812031
NCT01812031CompletedNot Applicable

Benefits Study of a Respiratory Gating Protocol for Positron Emission Tomography: Application on the Lungs

Centre Hospitalier Universitaire, Amiens2 sites in 1 country103 target enrollmentStarted: August 1, 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
103
Locations
2
Primary Endpoint
Lesion SUVmax

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Lesion SUVmax

Time Frame: Day 1

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 Outcomes

  • Lung function test(Day 0)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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