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Evaluation of a Pneumotachograph (SPI) for the Production of PET and CT Acquisitions Synchronized With Breath for the Assessment of Extension of Lung Cancer (SPI COHERENCE)

Primary Purpose

Non Small Cell Lung Cancer, Lung Nodule

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

PET/CT 4D imaging in a synchronized mode centered on the thorax.

About this trial

This is an interventional diagnostic trial for Non Small Cell Lung Cancer focused on measuring Lung Cancer, PET/CT, FDG, Respiratory synchronization

Eligibility Criteria

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

Inclusion Criteria:

Patient for whom there is an indication of PET/CT 18FDG imaging for thoracic oncology ; this indication is consistent with the Standard Options Recommendations or was validated during Multidisciplinary Consultation Meeting :
- Either an extension assessment of non-small cell lung cancer;
- Either the characterization of single pulmonary nodule; Or - the definition of the target volume in radiotherapy.
Patient who meets the following criteria to be eligible for an PET/CT imaging:
- Patient able to maintain a supine position for 60 minutes
- Patient with no bronchopulmonary infection and with no upper aero digestive tract acute infection in progress (increased risk of false positives)
Age ≥ 18 years
WHO ≤ 1
Well-informed written consent signed by the patient and collected before any specific procedure in the study
Patient member in a national insurance scheme

Exclusion Criteria:

Patient with a bronchial carcinoid or bronchoalveolar cancer
Patient with acute bronchopneumopathy
Not stabilized diabetic patient
Patient with an absolute indication against spirometry: ongoing pneumothorax or within the previous month, pleural biopsy or puncture within the previous month, hemoptysis, severe asthma, tuberculosis
Any usual relative indication against spirometry: ongoing bronchial infections, acute asthma, decompensation of chronic respiratory failure, respiratory pain
Any usual formal indication against imaging examination PET/CT (important claustrophobia)
Patient unable to follow study procedures
Pregnant women or nursing mothers can not participate in the study
Men and women of childbearing age must use effective contraception at study entry and throughout the study
Any other medical conditions making the inclusion of the patient in the study inappropriate in the opinion of the investigator
Patient under legal guardianship

Sites / Locations

Institut Claudius REGAUD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SPI Medical device

reference medical device : RPM

Arm Description

SPI medical device used during PET/CT 4D imaging in a synchronized mode centered on the thorax.

Reference medical device (RPM) used simultaneously during PET/CT 4D imaging in a synchronized mode centered on the thorax.

Outcomes

Primary Outcome Measures

Feasibility of the PET/CT synchronized exam with SPI device ("success" or "failure" )

feasibility is evaluated in a composite end point (success will be obtained in case of concomitant success of the 4 sub-criteria assessment): Tolerance / acceptability of the patient to breathe into SPI throughout the examination) Detection of breath cycle of the patient by measuring dCycleSpi (dCycleSpi = Number of synchronization signals emitted by SPI / total number of breath cycle * 100). Accuracy of detection of inspiratory peak amplitudes with SPI medical device: by measuring dtSpi (dtSpi = standard deviation of the time lag between synchronization signals and maximum inspiratory amplitude for each cycle). Production of images with a correct segmentation of BTV during PET/CT synchronized exam with SPI device"

Secondary Outcome Measures

Measure of dCycleRpm (dCycleRpmi = Number of synchronization signals emitted by RPM / total number of breath cycle * 100)

Accuracy of detection of maximum inspiratory amplitudes with RPM medical device: evaluated by measuring dtRpm

dtRpm = standard deviation of the time lag between synchronization signals and maximum inspiratory amplitude for each cycle

Measure of BTVrpm (= biologic tumoral volume)

Full Information

NCT ID

NCT01720186

First Posted

October 12, 2012

Last Updated

October 8, 2014

Sponsor

Institut Claudius Regaud

1. Study Identification

Unique Protocol Identification Number

NCT01720186

Brief Title

Evaluation of a Pneumotachograph (SPI) for the Production of PET and CT Acquisitions Synchronized With Breath for the Assessment of Extension of Lung Cancer

Acronym

SPI COHERENCE

Official Title

Evaluation of a Pneumotachograph (SPI) for the Production of PET and CT Acquisitions Synchronized With Breath for the Assessment of Extension of Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Terminated

Study Start Date

May 2013 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Claudius Regaud

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a pilot study, single-center, prospective, open-label, to assess the acceptability and performance of the experimental medical device (SPI) used during an imaging examination (PET / CT 4D imaging in synchronized mode centered on the thorax). Each patient will be its own control, since the imaging examination will be synchronized simultaneously with the two systems: tested Medical Device (SPI) and reference Medical Device(RPM).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer, Lung Nodule

Keywords

Lung Cancer, PET/CT, FDG, Respiratory synchronization

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SPI Medical device

Arm Type

Experimental

Arm Description

SPI medical device used during PET/CT 4D imaging in a synchronized mode centered on the thorax.

Arm Title

reference medical device : RPM

Arm Type

Active Comparator

Arm Description

Reference medical device (RPM) used simultaneously during PET/CT 4D imaging in a synchronized mode centered on the thorax.

Intervention Type

Device

Intervention Name(s)

PET/CT 4D imaging in a synchronized mode centered on the thorax.

Primary Outcome Measure Information:

Title

Feasibility of the PET/CT synchronized exam with SPI device ("success" or "failure" )

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Measure of dCycleRpm (dCycleRpmi = Number of synchronization signals emitted by RPM / total number of breath cycle * 100)

Time Frame

2 years

Title

Accuracy of detection of maximum inspiratory amplitudes with RPM medical device: evaluated by measuring dtRpm

Description

dtRpm = standard deviation of the time lag between synchronization signals and maximum inspiratory amplitude for each cycle

Time Frame

2 years

Title

Measure of BTVrpm (= biologic tumoral volume)

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient for whom there is an indication of PET/CT 18FDG imaging for thoracic oncology ; this indication is consistent with the Standard Options Recommendations or was validated during Multidisciplinary Consultation Meeting : Either an extension assessment of non-small cell lung cancer; Either the characterization of single pulmonary nodule; Or - the definition of the target volume in radiotherapy. Patient who meets the following criteria to be eligible for an PET/CT imaging: Patient able to maintain a supine position for 60 minutes Patient with no bronchopulmonary infection and with no upper aero digestive tract acute infection in progress (increased risk of false positives) Age ≥ 18 years WHO ≤ 1 Well-informed written consent signed by the patient and collected before any specific procedure in the study Patient member in a national insurance scheme Exclusion Criteria: Patient with a bronchial carcinoid or bronchoalveolar cancer Patient with acute bronchopneumopathy Not stabilized diabetic patient Patient with an absolute indication against spirometry: ongoing pneumothorax or within the previous month, pleural biopsy or puncture within the previous month, hemoptysis, severe asthma, tuberculosis Any usual relative indication against spirometry: ongoing bronchial infections, acute asthma, decompensation of chronic respiratory failure, respiratory pain Any usual formal indication against imaging examination PET/CT (important claustrophobia) Patient unable to follow study procedures Pregnant women or nursing mothers can not participate in the study Men and women of childbearing age must use effective contraception at study entry and throughout the study Any other medical conditions making the inclusion of the patient in the study inappropriate in the opinion of the investigator Patient under legal guardianship

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frederic COURBON, PhD

Organizational Affiliation

Institut Claudius Regaud

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Claudius REGAUD

City

Toulouse

ZIP/Postal Code

31052

Country

France

12. IPD Sharing Statement

Learn more about this trial

Evaluation of a Pneumotachograph (SPI) for the Production of PET and CT Acquisitions Synchronized With Breath for the Assessment of Extension of Lung Cancer

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