LungcancerIRMomicsNCT02977663
Imaging Multiparametric/Multimodality for Lungcancer
A study testing Magnetic Resonance Imaging (MRI) in people with Lungcancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
1. To build an imaging biobank of 200 patients with lungcancer, including pathologic and molecular characteristics of the tumor (mutational status, circulating DeoxyriboNucleic Acid (DNA) from serum biobank…), staging of the cancer (according to the new 2016 Tumor Node Metastasis (TNM) status, the table that classify… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lungcancer
- What is being tested?
- Magnetic Resonance Imaging (MRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 28 Aug 2017to Aug 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
- Adults over 18 years
- High suspicion of lungcancer confirmed
- Tumor > 2 cm
- Incomplete cerebral staging or not yet realized in the initial consultation of screening
Who cannot join
- Lungcancer medical history
- During Pregnancy
- Contraindications to MRI
- Patient not able to understand the information of the protocol, taking into account the state of the brain
- Patient unable to keep lying in MRI the necessary time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Imaging Multiparametric/Multimodality (Magnetic Resonance Imaging Combined With Positron Emission Tomography) for Lungcancer
- To build an imaging biobank of 200 patients with lungcancer, including pathologic and molecular characteristics of the tumor (mutational status, circulating DeoxyriboNucleic Acid (DNA) from serum biobank…), staging of the cancer (according to the new 2016 Tumor Node Metastasis (TNM) status, the table that classify non-small cell lungcancer) and follow-up informations (Response to first-line treatment (Response Evaluation Criteria in Solid Tumors (RECIST)), disease-free survival, 1-3 years survival).
- To propose a simple severity scoring system based on tumor features such as size, doubling time (if available), location, amount of enhancement and necrosis. Such approach has been proposed for glioma evaluation (Visually Accessible Rembrandt Images (VASARI)) but is not available for the lung. The objective is to do better than the Tumor Node Metastasis (TNM) staging.
- To develop and evaluate an IntraVoxel Incoherent Motion (IVIM) protocol for lungcancer evaluation.
- Conditions
- Lungcancer
- Being tested
- Magnetic Resonance Imaging (MRI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Other
- Chest MRI during the MRI cerebral
- 2 tubes of blood taken during the medical visit
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Resonance Imaging (MRI) | Other | Thoracic Magnetic Resonance Imaging (MRI) Receives: Other: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival of patients with lungcancer
Measured: 3 years
Secondary outcomes (7)
Overall survival
Measured: 3 months, 1 year, 2 years and 3 years
Number of patients by histologic subtypes
Measured: 3 months, 1 year, 2 years and 3 years
Number of patients by mutational profile
Measured: 3 months, 1 year, 2 years and 3 years
Number of patients with metastases
Measured: 3 months, 1 year, 2 years and 3 years
Number of patients with brain metastases
Measured: 3 months, 1 year, 2 years and 3 years
Number of metastases by patient
Measured: 3 months, 1 year, 2 years and 3 years
Therapeutic responses assessed by scanner/MRI and/or Positron Emission Tomography (PET) based on consensus criteria (RECIST 1.1 and PET Response Criteria in Solid Tumors (PERCIST))
Measured: 3 months, 1 year, 2 years and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study start28 Aug 2017
- Primary completionAug 2022 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LungcancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977663
- Sponsor's protocol ID
- K160701
- Other IDs
- ANSM
- Acronym
- IRMomics
- Status last verified
- Dec 2020
- First submitted
- 10 Nov 2016
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Multiparametric/Multimodality (Magnetic Resonance Imaging Combined With Positron Emission Tomography) for Lungcancer
- ClinicalTrials.gov ID
- NCT02977663
- Acronym / sponsor ID
- IRMomics / K160701
- Conditions
- Lungcancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- General Electric
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 30 Nov 2016 (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.
- To build an imaging biobank of 200 patients with lungcancer, including pathologic and molecular characteristics of the tumor (mutational status, circulating DeoxyriboNucleic Acid (DNA) from serum biobank…), staging of the cancer (according to the new 2016 Tumor Node Metastasis (TNM) status, the table that classify non-small cell lungcancer) and follow-up informations (Response to first-line treatment (Response Evaluation Criteria in Solid Tumors (RECIST)), disease-free survival, 1-3 years survival).
- To propose a simple severity scoring system based on tumor features such as size, doubling time (if available), location, amount of enhancement and necrosis. Such approach has been proposed for glioma evaluation (Visually Accessible Rembrandt Images (VASARI)) but is not available for the lung. The objective is to do better than the Tumor Node Metastasis (TNM) staging.
- To develop and evaluate an IntraVoxel Incoherent Motion (IVIM) protocol for lungcancer evaluation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic Resonance Imaging (MRI) | Other | Other: Magnetic Resonance Imaging (MRI)Thoracic Magnetic Resonance Imaging (MRI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults over 18 years
- High suspicion of lungcancer confirmed
- Tumor > 2 cm
- Incomplete cerebral staging or not yet realized in the initial consultation of screening
Key exclusion criteria (5 listed)
- Lungcancer medical history
- During Pregnancy
- Contraindications to MRI
- Patient not able to understand the information of the protocol, taking into account the state of the brain
- Patient unable to keep lying in MRI the necessary time
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 |
|---|---|---|
| Magnetic Resonance Imaging (MRI)* Chest MRI during the MRI cerebral * 2 tubes of blood taken during the medical visit | Other | Magnetic Resonance Imaging (MRI) |
Primary outcome
Event-free survival of patients with lungcancer
Time frame: 3 years
7 secondary outcomes
Overall survival
Time frame: 3 months, 1 year, 2 years and 3 years
Number of patients by histologic subtypes
Time frame: 3 months, 1 year, 2 years and 3 years
Number of patients by mutational profile
Time frame: 3 months, 1 year, 2 years and 3 years
Number of patients with metastases
Time frame: 3 months, 1 year, 2 years and 3 years
Number of patients with brain metastases
Time frame: 3 months, 1 year, 2 years and 3 years
Number of metastases by patient
Time frame: 3 months, 1 year, 2 years and 3 years
Therapeutic responses assessed by scanner/MRI and/or Positron Emission Tomography (PET) based on consensus criteria (RECIST 1.1 and PET Response Criteria in Solid Tumors (PERCIST))
Time frame: 3 months, 1 year, 2 years and 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging (MRI) in people with Lungcancer, run by Assistance Publique - Hôpitaux de Paris 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 4 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 8 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabine Helfen (33148957732, sabine.helfen@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival of patients with lungcancer (time frame: 3 years). 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 8 Jan 2021.