NeoplasmsNCT03553368
Chest Imaging of Lung Nodule(s) Under High-frequency Non-invasive Ventilation (HF-NIV)
A study testing HF-NIV-MR, HF-NIV-PET and MR in people with Neoplasms, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
Imaging of chest disorders is mainly achieved by using computed tomography. This is especially the case for detection, morphologic assessment and followup of pulmonary nodules. A positron emission tomography (PET) /CT may be additionally required for lung nodule management in some conditions including a size greater… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neoplasms
- What is being tested?
- HF-NIV-MR, HF-NIV-PET and MR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Jun 2018to 16 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Validated Informed Consent as documented by signature (Appendix Informed Consent Form)
- Depending on study arm:
- Good health (step 1 and 1 bis only) or
- Patients with at least 1 non calcified pulmonary nodule of at least 4 mm, whatever its texture (solid, sub-solid) and nature (benign, indeterminate or malignant), just discovered or in a follow-up context (step 2 only)
- Age ≥ 18 years
Who cannot join
- Previous or current disorder that might interfere with performance or safety of study procedures
- Age <18 years
- Any contraindication to MRI (pace makers, neuro-stimulators, some implantable devices, some metallic implants, claustrophobia)
- Any contraindication to a positive airway pressure therapy (claustrophobia, fracture of the skull, right heart failure), (step 1 bis)
- Children, adolescents and adults with incapacities
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Show all 17Show fewer
- Pregnant or breastfeeding women
- Chronic obstructive pulmonary disease (COPD) or asthma with severe obstruction
- Severe obstructive patients (FEV1<50% of predicted value)
- Hypoxemia (SaO2<94% AA)
- History or physical signs of right heart failure
- History or physical signs of right or left cardiac failure
- History or physical signs of pulmonary hypertension
- History or physical signs of active coronary artery disease
- Pulmonary graft
- Immunocompromized patients
- Enrollment of the investigator, his/her family members, employees and other dependent persons
Trial locations and contacts
1 site in 1 country.
About this study
Imaging of chest disorders is mainly achieved by using computed tomography. This is especially the case for detection, morphologic assessment and followup of pulmonary nodules. A positron emission tomography (PET) /CT may be additionally required for lung nodule management in some conditions including a size greater than 8 mm with morphologic or growing characteristics suspicious of malignancy. Magnetic Resonance Imaging (MRI) represents however an interesting alternative diagnostic radiation-free method, in particular owing to the recent development of sequences dedicated to lung parenchyma analysis. A major limitation remains the control of respiratory artefacts.
High Frequency non-invasive ventilation, HF-NIV, has the potential to allow chest stabilization and is currently used in the department of radio-oncology at the Lausanne University Hospital. It has been recently applied to perform MRI and PET examinations at end inspiration during an "apnea " generated by the system. Continuous periods of respiratory stabilization of several minutes at end-inspiration are thus obtained, allowing prolonged MR and PET acquisitions with improvement of image quality as observed in our preliminary studies (Beigelman-Aubry et al., Prior et al.). Interestingly, the lung volume explored by using this ventilation technique is similar to that of CT studies, conversely to respiratory gated MR sequences which are currently performed at end-expiration, this potentially generating underevaluation of lung disorders especially at lung bases.
Read more
The present project aims to determine the impact of HF-NIV in the management of patients with pulmonary nodule(s). After a first step of optimization of acquisition parameters of HF-NIV-MR in healthy volunteers, the performances of MRI and PET/CT (when required) under this ventilation technique will be compared to the current method(s) of reference in cases of pulmonary nodule(s) (CT scan and PET when required) and histological data when available. All MRI and PET/CT (when required) acquisitions will be performed without the ventilation technique, as used in current practice, and with it.
The project was completed with an amendment to investigate MRI under continuous positive airway pressure (CPAP). The MR-CPAP combination will be evaluated with optimized parameters in healthy volunteers and compared to free-breathing acquisitions without any device.
- Conditions
- Neoplasms
- Being tested
- HF-NIV-MR, HF-NIV-PET, MR, PET/CT breath hold, CPAP-MR
- Keywords
- lung nodules
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HF-NIV-MRDiagnostic test
MRI data will be acquired with the use of HF-NIV.
HF-NIV-PETDiagnostic test
PET data will be acquired with the use of HF-NIV.
MRDiagnostic test
MRI data will be acquired without the use of any device as a reference.
PET/CT breath holdDiagnostic test
PET/CT data will be acquired in inspiratory breath hold without the use of HF-NIV.
CPAP-MRDiagnostic test
MRI data will be acquired with the use of CPAP.
| Study group | Role | What they receive |
|---|---|---|
| Step 1: Healthy volunteers | Experimental | Experimental intervention:
MRI data will be acquired with the use of HF-NIV (HF-NIV-MR).
Control intervention:
MRI data will be acquired without the use of HF-NIV, as a reference (MR). Receives: Diagnostic Test: HF-NIV-MR; Diagnostic Test: MR |
| Step 2: Patients (arm A) | Experimental | Experimental intervention:
MRI data will be acquired with the use of HF-NIV (HF-NIV-MR).
Control intervention:
MRI data will also be acquired without the use of HF-NIV, as a reference (MR). The clinically prescribed CT will be the gold standard. Receives: Diagnostic Test: HF-NIV-MR; Diagnostic Test: MR |
| Step 2: Patients (arm B) | Experimental | Experimental intervention:
PET/CT data will be acquired with the use of HF-NIV (HF-NIV-PET). MRI data will be acquired with the use of HF-NIV (HF-NIV-MR). PET/CT data will be acquired in inspiratory breath hold without the use of HF-NIV (PET/CT breath hold).
Control intervention:
Data from the clinically indicated PET/CT acquisition will be used as reference.
MRI data will also be acquired without the use of HF-NIV, as a reference (MR). Histological data will be used when available. Receives: Diagnostic Test: HF-NIV-MR; Diagnostic Test: HF-NIV-PET; Diagnostic Test: MR; Diagnostic Test: PET/CT breath hold |
| Step 1 bis: Healthy volunteers | Experimental | Experimental intervention:
MRI data will be acquired with the use of CPAP (CPAP-MR).
Control intervention:
MRI data will be acquired without the use of CPAP, as a reference (MR). Receives: Diagnostic Test: MR; Diagnostic Test: CPAP-MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality, step 1: Healthy volunteers, sharpness of vessels
Sharpness of interfaces of vessels will be scored on a discrete scale as 1=blurred; 2=intermediate; 3=sharp. This will determine the adequate choice of MR sequences and parameters.
Measured: day 1
Sensitivity for nodule detection, step 2: Patients (arm A)
Determine whether HF-NIV-MR allows a better detection (higher sensitivity) of the presence of pulmonary nodules compared with conventional MR. CT will be used as gold standard.
Measured: day 1
Sensitivity for nodule characterization, step 2: Patients (arm B)
Determine whether sensitivity of the apparent diffusion coefficient (ADC) value obtained with HF-NIV-MR (diffusion sequence) to characterize nodules is higher than the sensitivity obtained with conventional MRI. Histological data will be used as gold standard when available.
Measured: day 1
Assessment of CPAP-MR, step 1 bis: Healthy volunteers
Determine whether CPAP-MR has an additional value compared with MR. Image quality of the CPAP-MR acquisition will be evaluated similarly to the methodology of step 1 and compared to the gold standard MR acquisition (free-breathing without any device).
Measured: day 1
Secondary outcomes (11)
Image quality, step 1: Healthy volunteers, sharpness of bronchi
Sharpness of interfaces of bronchi will be scored on a discrete scale as 1=blurred; 2=intermediate; 3=sharp.
Measured: day 1
Image quality, step 1: Healthy volunteers, sharpness of fissures
Sharpness of interfaces of fissures will be scored on a discrete scale as 1=blurred; 2=intermediate; 3=sharp.
Measured: day 1
Image quality, step 1: Healthy volunteers, visibility of vessels
Modified criteria of Ohno (Ohno et al.) will be used and vessels will be scored as follows 0=non visible; 1=depicted at a lobar level; 2=depicted at a segmental level; 3=depicted at a sub-segmental level; 4=depicted at a sub-sub segmental level; 5=depicted beyond the sub-subsegmental level.
Measured: day 1
Image quality, step 1: Healthy volunteers, visibility of bronchi
Modified criteria of Ohno (Ohno et al.) will be used and bronchi will be scored as follows 0=non visible; 1=depicted at a lobar level; 2=depicted at a segmental level; 3=depicted at a sub-segmental level; 4=depicted at a sub-sub segmental level; 5=depicted beyond the sub-subsegmental level.
Measured: day 1
Image quality, step 1: Healthy volunteers, visibility of fissures
Fissures will be scored as follows 0=non visible; 1=visible.
Measured: day 1
Nodule dimensions
The variable of interest will be the volumetry of each nodule detected which will be evaluated by using dedicated software. This will be compared with volumetric assessment by using CT performed less than 1 month before the MR examination, at best the same day.
Two-Dimensional measurements (long axis, mean of the long and short diameter) will also be used, in accordance with usual recommendations [MacMahon et al.].
Measured: day 1
MR-PET fusion
Fusion of MR acquisitions and PET under HF-NIV should be obtained with a good accuracy. The correspondence will be evaluated with a fiducial anatomical structures technique, as if acquisitions were done on a PET-MR scanner.
Measured: day 1
Correlation of diffusion MRI with metabolic activity
The correlation between ADC (diffusion coefficient) and metabolic activity in HF-NIV-PET/CT, will be compared to the one obtained without HF-NIV.
Measured: day 1
PET/CT stabilization assessment
The PET/CT image stabilization methods will compared and the best one will be determined (electronic respiratory-gating during the normal free-breathing PET/CT, a single short PET/CT apnea (<30 seconds) and the HF-NIV-PET/CT acquisition.
Measured: day 1
Correlation with ex-vivo nodule volume
When applicable, the volume of lesions measured on imaging studies will be compared to the volume measured ex-vivo following surgical resection.
Measured: day 1
Tolerance CPAP-MR, step 1 bis: Healthy volunteers
Subject subjective tolerance to CPAP-MR will be scored on a 5 points discrete scale as follows: 0=no additional discomfort, 1=minor discomfort, 2=moderate discomfort, 3=high discomfort, 4=extreme discomfort (same methodology as for steps 1 and 2).
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start14 Jun 2018
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Principal investigator, Beigelman-Aubry Catherine, University of Lausanne Hospitals
- Investigators
- Catherine Beigelman-Aubry, MD, Principal investigator, University Hospital Lausanne (CHUV), Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553368
- Sponsor's protocol ID
- HF-NIV-MR-PET
- Status last verified
- Oct 2020
- First submitted
- 15 May 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beigelman-Aubry C, Peguret N, Stuber M, Delacoste J, Belmondo B, Lovis A, Simons J, Long O, Grant K, Berchier G, Rohner C, Bonanno G, Coppo S, Schwitter J, Ozsahin M, Qanadli S, Meuli R, Bourhis J. Chest-MRI under pulsatile flow ventilation: A new promising technique. PLoS One. 2017 Jun 12;12(6):e0178807. doi: 10.1371/journal.pone.0178807. eCollection 2017.
PubMed 28604833Prior JO, Peguret N, Pomoni A, Pappon M, Zeverino M, Belmondo B, Lovis A, Ozsahin M, Vienne M, Bourhis J. Reduction of Respiratory Motion During PET/CT by Pulsatile-Flow Ventilation: A First Clinical Evaluation. J Nucl Med. 2016 Mar;57(3):416-9. doi: 10.2967/jnumed.115.163386. Epub 2015 Dec 3.
PubMed 26635339MacMahon H, Naidich DP, Goo JM, Lee KS, Leung ANC, Mayo JR, Mehta AC, Ohno Y, Powell CA, Prokop M, Rubin GD, Schaefer-Prokop CM, Travis WD, Van Schil PE, Bankier AA. Guidelines for Management of Incidental Pulmonary Nodules Detected on CT Images: From the Fleischner Society 2017. Radiology. 2017 Jul;284(1):228-243. doi: 10.1148/radiol.2017161659. Epub 2017 Feb 23.
PubMed 28240562Ohno Y, Koyama H, Yoshikawa T, Seki S, Takenaka D, Yui M, Lu A, Miyazaki M, Sugimura K. Pulmonary high-resolution ultrashort TE MR imaging: Comparison with thin-section standard- and low-dose computed tomography for the assessment of pulmonary parenchyma diseases. J Magn Reson Imaging. 2016 Feb;43(2):512-32. doi: 10.1002/jmri.25008. Epub 2015 Jul 30.
PubMed 26223818Darcot E, Delacoste J, Dunet V, Dournes G, Rotzinger D, Bernasconi M, Vremaroiu P, Simons J, Long O, Rohner C, Ledoux JB, Stuber M, Lovis A, Beigelman-Aubry C. Lung MRI assessment with high-frequency noninvasive ventilation at 3 T. Magn Reson Imaging. 2020 Dec;74:64-73. doi: 10.1016/j.mri.2020.09.006. Epub 2020 Sep 6.
PubMed 32898653
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest Imaging of Lung Nodule(s) Under High-frequency Non-invasive Ventilation (HF-NIV)
- ClinicalTrials.gov ID
- NCT03553368
- Acronym / sponsor ID
- HF-NIV-MR-PET
- Conditions
- Neoplasms
- Keywords
- lung nodules
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Imaging of chest disorders is mainly achieved by using computed tomography. This is especially the case for detection, morphologic assessment and followup of pulmonary nodules. A positron emission tomography (PET) /CT may be additionally required for lung nodule management in some conditions including a size greater than 8 mm with morphologic or growing characteristics suspicious of malignancy. Magnetic Resonance Imaging (MRI) represents however an interesting alternative diagnostic radiation-free method, in particular owing to the recent development of sequences dedicated to lung parenchyma analysis. A major limitation remains the control of respiratory artefacts.
High Frequency non-invasive ventilation, HF-NIV, has the potential to allow chest stabilization and is currently used in the department of radio-oncology at the Lausanne University Hospital. It has been recently applied to perform MRI and PET examinations at end inspiration during an "apnea " generated by the system. Continuous periods of respiratory stabilization of several minutes at end-inspiration are thus obtained, allowing prolonged MR and PET acquisitions with improvement of image quality as observed in our preliminary studies (Beigelman-Aubry et al., Prior et al.). Interestingly, the lung volume explored by using this ventilation technique is similar to that of CT studies, conversely to respiratory gated MR sequences which are currently performed at end-expiration, this potentially generating underevaluation of lung disorders especially at lung bases.
The present project aims to determine the impact of HF-NIV in the management of patients with pulmonary nodule(s). After a first step of optimization of acquisition parameters of HF-NIV-MR in healthy volunteers, the performances of MRI and PET/CT (when required) under this ventilation technique will be compared to the current method(s) of reference in cases of pulmonary nodule(s) (CT scan and PET when required) and histological data when available. All MRI and PET/CT (when required) acquisitions will be performed without the ventilation technique, as used in current practice, and with it.
The project was completed with an amendment to investigate MRI under continuous positive airway pressure (CPAP). The MR-CPAP combination will be evaluated with optimized parameters in healthy volunteers and compared to free-breathing acquisitions without any device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Step 1: Healthy volunteers | Experimental | Diagnostic Test: HF-NIV-MR, Diagnostic Test: MRExperimental intervention: MRI data will be acquired with the use of HF-NIV (HF-NIV-MR). Control intervention: MRI data will be acquired without the use of HF-NIV, as a reference (MR). |
| Step 2: Patients (arm A) | Experimental | Diagnostic Test: HF-NIV-MR, Diagnostic Test: MRExperimental intervention: MRI data will be acquired with the use of HF-NIV (HF-NIV-MR). Control intervention: MRI data will also be acquired without the use of HF-NIV, as a reference (MR). The clinically prescribed CT will be the gold standard. |
| Step 2: Patients (arm B) | Experimental | Diagnostic Test: HF-NIV-MR, Diagnostic Test: HF-NIV-PET, Diagnostic Test: MR, Diagnostic Test: PET/CT breath holdExperimental intervention: PET/CT data will be acquired with the use of HF-NIV (HF-NIV-PET). MRI data will be acquired with the use of HF-NIV (HF-NIV-MR). PET/CT data will be acquired in inspiratory breath hold without the use of HF-NIV (PET/CT breath hold). Control intervention: Data from the clinically indicated PET/CT acquisition will be used as reference. MRI data will also be acquired without the use of HF-NIV, as a reference (MR). Histological data will be used when available. |
| Step 1 bis: Healthy volunteers | Experimental | Diagnostic Test: MR, Diagnostic Test: CPAP-MRExperimental intervention: MRI data will be acquired with the use of CPAP (CPAP-MR). Control intervention: MRI data will be acquired without the use of CPAP, as a reference (MR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Validated Informed Consent as documented by signature (Appendix Informed Consent Form)
- Depending on study arm:
- Good health (step 1 and 1 bis only) or
- Patients with at least 1 non calcified pulmonary nodule of at least 4 mm, whatever its texture (solid, sub-solid) and nature (benign, indeterminate or malignant), just discovered or in a follow-up context (step 2 only)
- Age ≥ 18 years
Key exclusion criteria (17 listed)
- Previous or current disorder that might interfere with performance or safety of study procedures
- Age <18 years
- Any contraindication to MRI (pace makers, neuro-stimulators, some implantable devices, some metallic implants, claustrophobia)
- Any contraindication to a positive airway pressure therapy (claustrophobia, fracture of the skull, right heart failure), (step 1 bis)
- Children, adolescents and adults with incapacities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HF-NIV-MRMRI data will be acquired with the use of HF-NIV. | Diagnostic test | Step 1: Healthy volunteers, Step 2: Patients (arm A), Step 2: Patients (arm B) |
| HF-NIV-PETPET data will be acquired with the use of HF-NIV. | Diagnostic test | Step 2: Patients (arm B) |
| MRMRI data will be acquired without the use of any device as a reference. | Diagnostic test | Step 1 bis: Healthy volunteers, Step 1: Healthy volunteers, Step 2: Patients (arm A), Step 2: Patients (arm B) |
| PET/CT breath holdPET/CT data will be acquired in inspiratory breath hold without the use of HF-NIV. | Diagnostic test | Step 2: Patients (arm B) |
| CPAP-MRMRI data will be acquired with the use of CPAP. | Diagnostic test | Step 1 bis: Healthy volunteers |
Primary outcome
Image quality, step 1: Healthy volunteers, sharpness of vessels
Time frame: day 1
Sharpness of interfaces of vessels will be scored on a discrete scale as 1=blurred; 2=intermediate; 3=sharp. This will determine the adequate choice of MR sequences and parameters.
Sensitivity for nodule detection, step 2: Patients (arm A)
Time frame: day 1
Determine whether HF-NIV-MR allows a better detection (higher sensitivity) of the presence of pulmonary nodules compared with conventional MR. CT will be used as gold standard.
Sensitivity for nodule characterization, step 2: Patients (arm B)
Time frame: day 1
Determine whether sensitivity of the apparent diffusion coefficient (ADC) value obtained with HF-NIV-MR (diffusion sequence) to characterize nodules is higher than the sensitivity obtained with conventional MRI. Histological data will be used as gold standard when available.
Assessment of CPAP-MR, step 1 bis: Healthy volunteers
Time frame: day 1
Determine whether CPAP-MR has an additional value compared with MR. Image quality of the CPAP-MR acquisition will be evaluated similarly to the methodology of step 1 and compared to the gold standard MR acquisition (free-breathing without any device).
11 secondary outcomes
Image quality, step 1: Healthy volunteers, sharpness of bronchi
Time frame: day 1
Image quality, step 1: Healthy volunteers, sharpness of fissures
Time frame: day 1
Image quality, step 1: Healthy volunteers, visibility of vessels
Time frame: day 1
Image quality, step 1: Healthy volunteers, visibility of bronchi
Time frame: day 1
Image quality, step 1: Healthy volunteers, visibility of fissures
Time frame: day 1
Nodule dimensions
Time frame: day 1
MR-PET fusion
Time frame: day 1
Correlation of diffusion MRI with metabolic activity
Time frame: day 1
PET/CT stabilization assessment
Time frame: day 1
Correlation with ex-vivo nodule volume
Time frame: day 1
Tolerance CPAP-MR, step 1 bis: Healthy volunteers
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 28604833Beigelman-Aubry C, Peguret N, Stuber M, Delacoste J, Belmondo B, Lovis A, Simons J, Long O, Grant K, Berchier G, Rohner C, Bonanno G, Coppo S, Schwitter J, Ozsahin M, Qanadli S, Meuli R, Bourhis J. Chest-MRI under pulsatile flow ventilation: A new promising technique. PLoS One. 2017 Jun 12;12(6):e0178807. doi: 10.1371/journal.pone.0178807. eCollection 2017.
- Background: PubMed 26635339Prior JO, Peguret N, Pomoni A, Pappon M, Zeverino M, Belmondo B, Lovis A, Ozsahin M, Vienne M, Bourhis J. Reduction of Respiratory Motion During PET/CT by Pulsatile-Flow Ventilation: A First Clinical Evaluation. J Nucl Med. 2016 Mar;57(3):416-9. doi: 10.2967/jnumed.115.163386. Epub 2015 Dec 3.
- Background: PubMed 28240562MacMahon H, Naidich DP, Goo JM, Lee KS, Leung ANC, Mayo JR, Mehta AC, Ohno Y, Powell CA, Prokop M, Rubin GD, Schaefer-Prokop CM, Travis WD, Van Schil PE, Bankier AA. Guidelines for Management of Incidental Pulmonary Nodules Detected on CT Images: From the Fleischner Society 2017. Radiology. 2017 Jul;284(1):228-243. doi: 10.1148/radiol.2017161659. Epub 2017 Feb 23.
- Background: PubMed 26223818Ohno Y, Koyama H, Yoshikawa T, Seki S, Takenaka D, Yui M, Lu A, Miyazaki M, Sugimura K. Pulmonary high-resolution ultrashort TE MR imaging: Comparison with thin-section standard- and low-dose computed tomography for the assessment of pulmonary parenchyma diseases. J Magn Reson Imaging. 2016 Feb;43(2):512-32. doi: 10.1002/jmri.25008. Epub 2015 Jul 30.
- Results publication: PubMed 32898653Darcot E, Delacoste J, Dunet V, Dournes G, Rotzinger D, Bernasconi M, Vremaroiu P, Simons J, Long O, Rohner C, Ledoux JB, Stuber M, Lovis A, Beigelman-Aubry C. Lung MRI assessment with high-frequency noninvasive ventilation at 3 T. Magn Reson Imaging. 2020 Dec;74:64-73. doi: 10.1016/j.mri.2020.09.006. Epub 2020 Sep 6.
- Individual participant dataSharing planned: No
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Beigelman-Aubry, MD principal investigator
University Hospital Lausanne (CHUV), Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HF-NIV-MR, HF-NIV-PET and MR in people with Neoplasms, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality, step 1: Healthy volunteers, sharpness of vessels (time frame: day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03553368, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.