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

NCT ID: NCT01720186

Last Updated: 2014-10-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-09-30

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).

Conditions

Non Small Cell Lung Cancer; Lung Nodule

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

SPI Medical device

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

reference medical device : RPM

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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)

3. Age ≥ 18 years

4. WHO ≤ 1

5. Well-informed written consent signed by the patient and collected before any specific procedure in the study

6. Patient member in a national insurance scheme

Exclusion Criteria

1. Patient with a bronchial carcinoid or bronchoalveolar cancer

2. Patient with acute bronchopneumopathy

3. Not stabilized diabetic patient

4. 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

5. Any usual relative indication against spirometry: ongoing bronchial infections, acute asthma, decompensation of chronic respiratory failure, respiratory pain

6. Any usual formal indication against imaging examination PET/CT (important claustrophobia)

7. Patient unable to follow study procedures

8. Pregnant women or nursing mothers can not participate in the study

9. Men and women of childbearing age must use effective contraception at study entry and throughout the study

10. Any other medical conditions making the inclusion of the patient in the study inappropriate in the opinion of the investigator

11. Patient under legal guardianship

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederic COURBON, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Claudius Regaud

Locations

Institut Claudius REGAUD

Toulouse, , France

Countries

France

Other Identifiers

12POUM01

Identifier Type: -

Identifier Source: org_study_id