Pulmonary NodulesNCT05067023
Evaluation for Benign and Malignant Pulmonary Ground-glass Nodules Based on MRI Dynamic Contrast Enhanced Imaging
A study testing MRI scan in people with Pulmonary Nodules, run by Qianfoshan Hospital.
Trial summary
Computed tomography (CT) is critical for the diagnosis of lung nodules as well as for therapeutic management. Repeated CT examinations will raise the issue of the cumulative radiation dose and subsequent risk of cancer, thus pushing the need for imaging techniques using low or no radiation dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Nodules
- What is being tested?
- MRI scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2021to 15 Mar 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ground-glass pulmonary nodules found by CT scan
- Plan to accept surgery or puncture due to the pulmonary nodules
- Absence of treatment such as chemotherapy or radiotherapy and biopsy
- Adequate renal function to tolerate intravenous gadolinium
- Agree to sign informed consent
- Able to lie still during DCE-MRI
Who cannot join
- Fail to understand or agree to sign informed consent
- Implanted pacemaker or cardiac defibrillator
- Contraindications to undergoing MRI
- Uncontrolled intercurrent illness
- Pregnant or breastfeeding
About this study
Computed tomography (CT) is critical for the diagnosis of lung nodules as well as for therapeutic management. Repeated CT examinations will raise the issue of the cumulative radiation dose and subsequent risk of cancer, thus pushing the need for imaging techniques using low or no radiation dose. Magnetic Resonance Imagery (MRI) with ultrashort echo time (UTE) pulse sequences with high signal-to-noise and spatial resolution is a promising alternative for lung nodules imaging.The purpose of the study is to evaluate the value of dynamic contrast-enhanced MR imaging (DCE-MRI) to discriminate of malignant from benign lesions.
Read the detailed description
Computed tomography (CT) is critical for the diagnosis of lung nodules as well as for therapeutic management. Repeated CT examinations will raise the issue of the cumulative radiation dose and subsequent risk of cancer, thus pushing the need for imaging techniques using low or no radiation dose. Magnetic Resonance Imagery (MRI) with ultrashort echo time (UTE) pulse sequences with high signal-to-noise and spatial resolution is a promising alternative for lung nodules imaging.The purpose of the study is to evaluate the value of DCE-MRI to discriminate of malignant from benign lesions.In this study, the investigators are going to validate the efficacy of the DCE-MRI for diagnosing early lung cancer by comparing results of the pre-surgery MRI imaging with the post-surgery pathology.
- Conditions
- Pulmonary Nodules
- Being tested
- MRI scan
- Medical subject headings
- Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanDiagnostic test
All participants will undergo 1 DCE-MRI scan.
| Study group | Role | What they receive |
|---|---|---|
| MRI scan | Experimental | All participants will undergo 1 DCE-MRI scan before surgery or puncture. Receives: Diagnostic Test: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume transfer constant (Ktrans)
Pharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.
Measured: 12 months
the fractional volume of extravascular extracellular space of the target tissue (ve)
Pharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.
Measured: 12 months
the rate constant (kep)
Pharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start20 Nov 2021 (estimated)
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary NodulesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Cao, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067023
- Sponsor's protocol ID
- QianfoshanH Z
- Status last verified
- Oct 2021
- First submitted
- 9 Sep 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation for Benign and Malignant Pulmonary Ground-glass Nodules Based on MRI Dynamic Contrast Enhanced Imaging
- ClinicalTrials.gov ID
- NCT05067023
- Acronym / sponsor ID
- QianfoshanH Z
- Conditions
- Pulmonary Nodules
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 20 Nov 2021 (estimated)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Mar 2023 (estimated)
- First posted
- 4 Oct 2021 (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.
Computed tomography (CT) is critical for the diagnosis of lung nodules as well as for therapeutic management. Repeated CT examinations will raise the issue of the cumulative radiation dose and subsequent risk of cancer, thus pushing the need for imaging techniques using low or no radiation dose. Magnetic Resonance Imagery (MRI) with ultrashort echo time (UTE) pulse sequences with high signal-to-noise and spatial resolution is a promising alternative for lung nodules imaging.The purpose of the study is to evaluate the value of dynamic contrast-enhanced MR imaging (DCE-MRI) to discriminate of malignant from benign lesions.
Detailed description
Computed tomography (CT) is critical for the diagnosis of lung nodules as well as for therapeutic management. Repeated CT examinations will raise the issue of the cumulative radiation dose and subsequent risk of cancer, thus pushing the need for imaging techniques using low or no radiation dose. Magnetic Resonance Imagery (MRI) with ultrashort echo time (UTE) pulse sequences with high signal-to-noise and spatial resolution is a promising alternative for lung nodules imaging.The purpose of the study is to evaluate the value of DCE-MRI to discriminate of malignant from benign lesions.In this study, the investigators are going to validate the efficacy of the DCE-MRI for diagnosing early lung cancer by comparing results of the pre-surgery MRI imaging with the post-surgery pathology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI scan | Experimental | Diagnostic Test: MRI scanAll participants will undergo 1 DCE-MRI scan before surgery or puncture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ground-glass pulmonary nodules found by CT scan
- Plan to accept surgery or puncture due to the pulmonary nodules
- Absence of treatment such as chemotherapy or radiotherapy and biopsy
- Adequate renal function to tolerate intravenous gadolinium
- Agree to sign informed consent
Key exclusion criteria (5 listed)
- Fail to understand or agree to sign informed consent
- Implanted pacemaker or cardiac defibrillator
- Contraindications to undergoing MRI
- Uncontrolled intercurrent illness
- Pregnant or breastfeeding
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 |
|---|---|---|
| MRI scanAll participants will undergo 1 DCE-MRI scan. | Diagnostic test | MRI scan |
Primary outcome
Volume transfer constant (Ktrans)
Time frame: 12 months
Pharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.
the fractional volume of extravascular extracellular space of the target tissue (ve)
Time frame: 12 months
Pharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.
the rate constant (kep)
Time frame: 12 months
Pharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing MRI scan in people with Pulmonary Nodules, run by Qianfoshan Hospital.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Volume transfer constant (Ktrans) (time frame: 12 months). The study lists 3 primary outcomes in all. 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 4 Oct 2021.