For Oncologic PatientsNCT02377518
DECT Ventilation Imaging
A study testing Single source dual energy compted tomography (CT750HD, General Electric, USA) with Krypton as a gaseous contrast media in people with For Oncologic Patients and Potentially Operable Lung Tumor, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Demonstrate the feasibility of dual energy computed tomography using Krypton as a gaseous contrast media in order to study the in vivo ventilation. Two different clinical situations will be tested : Prediction of postoperative pulmonary function for oncologic patients Detection of Bronchiolitis Obliterans in lung… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- For Oncologic Patients, Potentially Operable Lung Tumor, With a Recent (Less Than 1 Month) VQ Scan
- What is being tested?
- Single source dual energy compted tomography (CT750HD, General Electric, USA) with Krypton as a gaseous contrast media
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Jan 2016
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For oncologic patients :
- Potentially operable lung tumor
- With a recent (less than 1 month) V/Q scan
- For lung transplant recipients :
- Single of bilateral lung transplant
- From 5 months onwards
- With recent (less than 1 month) respiratory functional explorations
Who cannot join
- Impossibility to follow simple orders or control one's respiration
- Known Krypton hypersensitivity
- History of malignant hyperthermia
- Increased intracranial pressure
- Minors
- Pregnant Women
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Radiologie B - Nouvel Hôpital Civil - CHRU de Strasbourg
Strasbourg, 67091 Cedex
About this study
Official title: Quantitative Ventilation Imaging With Dual Energy Computed Tomography
Demonstrate the feasibility of dual energy computed tomography using Krypton as a gaseous contrast media in order to study the in vivo ventilation.
Two different clinical situations will be tested :
- Prediction of postoperative pulmonary function for oncologic patients
- Detection of Bronchiolitis Obliterans in lung transplant recipients.
- Conditions
- For Oncologic Patients, Potentially Operable Lung Tumor, With a Recent (Less Than 1 Month) VQ Scan, For Lung Transplant Recipients, Single of Bilateral Lung Transplant, From 5 Months Onwards
- Being tested
- Single source dual energy compted tomography (CT750HD, General Electric, USA) with Krypton as a gaseous contrast media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single source dual energy compted tomography (CT750HD, General Electric, USA) with Krypton as a gaseous contrast mediaRadiation
| Study group | Role | What they receive |
|---|---|---|
| oncologic patients | Experimental | Prediction of postoperative pulmonary function.
Patients with an operable lung cancer: dual energy computed tomography with Krypton will be tested to estimate the postoperative FEV1 Receives: Radiation: Single source dual energy compted tomography (CT750HD, General Electric, USA) with Krypton as a gaseous contrast media |
| lung transplant recipients | Experimental | Detection of BOS
6 months+ lung transplant recipients will be tested using dual energy computed tomography with Krypton, with acquisition in the end-inspiratory and end-expiratory phase, in search of regional air trapping. Receives: Radiation: Single source dual energy compted tomography (CT750HD, General Electric, USA) with Krypton as a gaseous contrast media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality on a qualitative 5 levels scale
Measured: 1 day of DECT ventilation imaging
Secondary outcomes (3)
Radiation dose
Measured: 1 day of DECT ventilation imaging
Image noise with measurement of signal to noise and contrast to noise ratios
Measured: 1 day of DECT ventilation imaging
Total examination time
Measured: 1 day of DECT ventilation imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Change of device used for dual energy computed tomography with Xenon
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for For Oncologic PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377518
- Sponsor's protocol ID
- 5601
- Status last verified
- Mar 2018
- First submitted
- 25 Feb 2015
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Ventilation Imaging With Dual Energy Computed Tomography
- ClinicalTrials.gov ID
- NCT02377518
- Acronym / sponsor ID
- 5601
- Conditions
- For Oncologic Patients, Potentially Operable Lung Tumor, With a Recent (Less Than 1 Month) VQ Scan, For Lung Transplant Recipients, Single of Bilateral Lung Transplant, From 5 Months Onwards
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change of device used for dual energy computed tomography with Xenon
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 3 Mar 2015 (estimated)
- 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.
Demonstrate the feasibility of dual energy computed tomography using Krypton as a gaseous contrast media in order to study the in vivo ventilation.
Two different clinical situations will be tested :
- Prediction of postoperative pulmonary function for oncologic patients
- Detection of Bronchiolitis Obliterans in lung transplant recipients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oncologic patients | Experimental | Radiation: Single source dual energy compted tomography (CT750HD, General Electric, USA) with Krypton as a gaseous contrast mediaPrediction of postoperative pulmonary function. Patients with an operable lung cancer: dual energy computed tomography with Krypton will be tested to estimate the postoperative FEV1 |
| lung transplant recipients | Experimental | Radiation: Single source dual energy compted tomography (CT750HD, General Electric, USA) with Krypton as a gaseous contrast mediaDetection of BOS 6 months+ lung transplant recipients will be tested using dual energy computed tomography with Krypton, with acquisition in the end-inspiratory and end-expiratory phase, in search of regional air trapping. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Potentially operable lung tumor
- With a recent (less than 1 month) V/Q scan
- Single of bilateral lung transplant
- From 5 months onwards
- With recent (less than 1 month) respiratory functional explorations
Key exclusion criteria (6 listed)
- Impossibility to follow simple orders or control one's respiration
- Known Krypton hypersensitivity
- History of malignant hyperthermia
- Increased intracranial pressure
- Minors
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 |
|---|---|---|
| Single source dual energy compted tomography (CT750HD, General Electric, USA) with Krypton as a gaseous contrast media | Radiation | lung transplant recipients, oncologic patients |
Primary outcome
Image quality on a qualitative 5 levels scale
Time frame: 1 day of DECT ventilation imaging
3 secondary outcomes
Radiation dose
Time frame: 1 day of DECT ventilation imaging
Image noise with measurement of signal to noise and contrast to noise ratios
Time frame: 1 day of DECT ventilation imaging
Total examination time
Time frame: 1 day of DECT ventilation imaging
Results and safety
The study was stopped early (reason given: Change of device used for dual energy computed tomography with Xenon). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single source dual energy compted tomography (CT750HD, General Electric, USA) with Krypton as a gaseous contrast media in people with For Oncologic Patients and Potentially Operable Lung Tumor, run by University Hospital, Strasbourg, France at 1 site in France.
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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 23 Mar 2018. 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 France. 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 was stopped early (reason given: Change of device used for dual energy computed tomography with Xenon). Results are not available in the source record.
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 on a qualitative 5 levels scale (time frame: 1 day of DECT ventilation imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2018; AzTrials last refreshed its copy on 2 Nov 2026.