Pulmonary Nodule Detection: Comparison of an Ultra Low Dose vs Standard Scan.

NCT ID: NCT03305978

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-26
• Study Completion Date: 2019-07-10

Brief Summary

Lung cancer screening programs are still discussed in Europe today, and one of the concern is radiation due to iterative CT. The aim of this monocentric, prospective, non randomized study is to compare an ultra low dose chest CT (approaching a two views X ray) versus a standard low dose chest CT for ≥4mm lung nodules detection, and secondary for lung nodule characterization and smoking associated findings (emphysema, bronchial abnormalities and coronary calcifications).

Detailed Description

An additional Ultra Low Dose CT, approaching 0.2mSv, will be performed in consenting patients referred for non enhanced chest CT in our Revolution CT scanner (GE Healthcare®).The dose delivered with the two acquisitions is still lower than the french diagnostic reference level. Standard CT is interpreted and a report is sent to the referent physician as usual. Then the two acquisitions are read over time by two independent radiologists, blinded over judgment criterias. In case of discordance, an other radiologist will arbitrate. We hope to validate our Ultra low dose chest CT protocol, which is more than 10 times less radiating than a standard low dose CT, as a sensitive tool to detect lung nodules.

Conditions

Lung Cancer; Smoking; Radiation Exposure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Ultra low dose chest CT

Group Type: EXPERIMENTAL

Ultra low dose chest CT

Intervention Type: DEVICE

An additional ultra low dose CT row is performed for every subject besides standard diagnostic low dose chest CT.

Low dose chest CT

Group Type: ACTIVE_COMPARATOR

Low dose chest CT

Intervention Type: DEVICE

standard diagnostic low dose chest CT

Interventions

Ultra low dose chest CT

An additional ultra low dose CT row is performed for every subject besides standard diagnostic low dose chest CT.

Intervention Type: DEVICE

Low dose chest CT

standard diagnostic low dose chest CT

Intervention Type: DEVICE

Other Intervention Names

Revolution CT (GE Healthcare) 442507CN0, equiped with ASIR V; Revolution CT (GE Healthcare)

Eligibility Criteria

Inclusion Criteria

1. Patients referred for non enhanced chest CT for following indications :

• lung nodule search or control
• nodular abnormality on chest X ray
• statement of COPD or emphysema
• asbestos exposure
• nodule localization before radio frequency ablation
• assessment of disease extent of an extra thoracic cancer (in case of iodinated intravenous contrast agent contraindication)
• statement before extrathoracic transplantation (in case of iodinated intravenous contrast agent contraindication)

2. Affiliated with the french social security

3. Who signed consent

Exclusion Criteria

1. Inability to lie down and still during the examination

2. Inability to hold breath more than 5 seconds

3. Pneumonia in the last 3 months

4. Body mass index more than 35kg/m²

5. exclusion period of another interventionnal study

6. referred for articles L1121-5 to L1121-8 of french public health code

7. Pregnant or breastfeeding women

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

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilbert Ferretti, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

University Hospital Grenoble

Grenoble, , France

Countries

France

References

Ludwig M, Chipon E, Cohen J, Reymond E, Medici M, Cole A, Moreau Gaudry A, Ferretti G. Detection of pulmonary nodules: a clinical study protocol to compare ultra-low dose chest CT and standard low-dose CT using ASIR-V. BMJ Open. 2019 Aug 15;9(8):e025661. doi: 10.1136/bmjopen-2018-025661.

Reference Type: DERIVED

PMID: 31420379 (View on PubMed)

Other Identifiers

38RC17.132

Identifier Type: -

Identifier Source: org_study_id