Contribution of the CEST Sequence in the Characterization of Radionecrosis of Brain Metastases of Pulmonary Origin
New MRI technique to better detect radiation damage in brain tumors
Plain English Summary
Contribution of the CEST Sequence in the Characterization of Radionecrosis of Brain Metastases of Pulmonary Origin is a Not Applicable clinical trial sponsored by Assistance Publique - Hôpitaux de Paris studying Brain Metastases, Radionecrosis, Pulmonary Cancer. This trial tests a new MRI scan technique to see if it can accurately identify radiation damage (radionecrosis) in brain tumors that have spread from lung cancer. It is for patients over 18 who have been treated for brain tumors originating from lung cancer and have had radiation therapy. Participation involves undergoing an MRI scan with an added 10-minute sequence, which may involve an injection. Standard MRI scans with contrast are the current method, but this study aims to see if the new technique is as good or better without needing contrast. The trial aims to enroll 60 participants.
Official Summary
The aim of the study is to determine whether the use of the CEST sequence would have diagnostic performance equivalent to the reference method of T2\* infusion with contrast injection in the diagnosis of radionecrosis of lung cancer brain metastases.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults (over 18) with a confirmed diagnosis of lung cancer that has spread to the brain, and who have received radiation treatment for these brain tumors. Patients whose brain tumors show changes on a recent MRI scan. Individuals must be covered by social security and able to give informed consent. People who cannot have an MRI, refuse imaging, have severe cognitive issues, or are under guardianship cannot participate. This trial is studying Brain Metastases, Radionecrosis, Pulmonary Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how well the new MRI technique can identify signs of radiation damage, aiming to be as accurate as the current standard method that uses contrast dye. The specific primary outcome measures are: Visually significant hyperperfusion on normalized cerebral blood flow mapping generated from T2* infusion data with injection, confirmed by quantitative measurement of a ratio > 2.5 between tumor DSC and contralateral white matter. (24 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it could lead to a more accurate and potentially less invasive way to diagnose radiation damage in brain tumors, improving treatment decisions for lung cancer patients. This research targets Brain Metastases, Radionecrosis, Pulmonary Cancer, where improved treatment options are needed.
Investor Insight
This trial focuses on a niche but critical area of oncology imaging, potentially improving diagnostic accuracy for a common complication of brain tumor treatment, which could have significant implicat
Is This Trial Right for Me?
Ask your doctor if this new MRI technique is suitable for you and what the potential benefits and risks are. Understand that participation means undergoing an MRI scan that will take about 10 minutes longer than a standard scan, and may involve an injection. Be prepared to discuss your medical history and any concerns you have about the procedure with the research team. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 60 participants
Interventions
- RADIATION: MRI with CEST sequence, IVIM and ASL sequence — Three sequences will be added as part of the protocol (for an additional duration of about 10 minutes) : * The CEST sequence * The ASL infusion sequence * The IVIM sequence
Primary Outcomes
- Visually significant hyperperfusion on normalized cerebral blood flow mapping generated from T2* infusion data with injection, confirmed by quantitative measurement of a ratio > 2.5 between tumor DSC and contralateral white matter. (24 months)
Secondary Outcomes
- Diagnostic performances for the IVIM sequence using IVIM scattering derivatives: f', ADC (24 months)
- Diagnostic performances for the ASL (arterial spin labeling) sequence using ASL infusion derivatives: intralesional CBF (cerebral blood flow) relative to contralateral white matter CBF (24 months)
- Diagnostic performances of coupled CEST, IVIM and ASL sequences, evaluated by the derivates of the CEST sequence : APT-AUC (Area Under Curve), NOE-MTR (Magnetization Transfer Ratio) and NOE-AUC. (24 months)
- Diagnostic performances of coupled CEST, IVIM and ASL sequences, evaluated by the derivates of the IVIM scattering : f', ADC (24 months)
- Diagnostic performance of coupled CEST, IVIM and ASL sequences, evaluated by the derivates of the ASL infusion : intralesional CBF (cerebral blood flow) relative to contralateral white matter CBF (24 months)
Full Eligibility Criteria
Inclusion Criteria: * Patients \> 18 years of age * Histologically proven primary lung cancer * Histologically proven or not brain metastases * Irradiated metastases * Inclusion in a treatment protocol for brain metastases by brain metastasis in toto or stereotactic or gamma-knife radiotherapy * Morphological increase of one or more lesions of secondary brain metastases on a follow-up MRI * Patients affiliated to a social security scheme Exclusion Criteria: * Opposition to the study * Contraindication to MRI * Refusal of imaging by the patient * Patient with state medical aid (unless exemption from affiliation) * Severe cognitive impairment making informed consent impossible * Patients under guardianship or deprived of liberty
Trial Locations
- Hôpital Bichat-Claude Bernard, Paris, France
Frequently Asked Questions
What is clinical trial NCT05977803?
NCT05977803 is a Not Applicable INTERVENTIONAL study titled "Contribution of the CEST Sequence in the Characterization of Radionecrosis of Brain Metastases of Pulmonary Origin." It is currently recruiting and is sponsored by Assistance Publique - Hôpitaux de Paris. The trial targets enrollment of 60 participants.
What conditions does NCT05977803 study?
This trial investigates treatments for Brain Metastases, Radionecrosis, Pulmonary Cancer. The primary condition under study is Brain Metastases.
What treatments are being tested in NCT05977803?
The interventions being studied include: MRI with CEST sequence, IVIM and ASL sequence (RADIATION). Three sequences will be added as part of the protocol (for an additional duration of about 10 minutes) : * The CEST sequence * The ASL infusion sequence * The IVIM sequence
What does Not Applicable mean for NCT05977803?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05977803?
This trial is currently "Recruiting." It started on 2024-02-15. The estimated completion date is 2029-03-15.
Who is sponsoring NCT05977803?
NCT05977803 is sponsored by Assistance Publique - Hôpitaux de Paris. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05977803?
The trial aims to enroll 60 participants. The trial is currently recruiting and accepting new participants.
How is NCT05977803 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT05977803?
The primary outcome measures are: Visually significant hyperperfusion on normalized cerebral blood flow mapping generated from T2* infusion data with injection, confirmed by quantitative measurement of a ratio > 2.5 between tumor DSC and contralateral white matter. (24 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05977803 being conducted?
This trial is being conducted at 1 site, including Paris (France).
Where can I find official information about NCT05977803?
The official record for NCT05977803 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05977803. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05977803 testing in simple terms?
This trial tests a new MRI scan technique to see if it can accurately identify radiation damage (radionecrosis) in brain tumors that have spread from lung cancer. It is for patients over 18 who have been treated for brain tumors originating from lung cancer and have had radiation therapy.
Why is this trial significant?
This trial matters because it could lead to a more accurate and potentially less invasive way to diagnose radiation damage in brain tumors, improving treatment decisions for lung cancer patients.
What are the potential risks of participating in NCT05977803?
The main risk is related to the MRI procedure itself, such as claustrophobia or reactions to any injected contrast agents. Potential side effects of the new MRI sequences are not fully known but are expected to be similar to standard MRI procedures. There is a small risk that the new technique may not be as accurate as hoped, leading to misdiagnosis. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05977803?
Ask your doctor if this new MRI technique is suitable for you and what the potential benefits and risks are. Understand that participation means undergoing an MRI scan that will take about 10 minutes longer than a standard scan, and may involve an injection. Be prepared to discuss your medical history and any concerns you have about the procedure with the research team. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05977803 signal from an investment perspective?
This trial focuses on a niche but critical area of oncology imaging, potentially improving diagnostic accuracy for a common complication of brain tumor treatment, which could have significant implicat This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves undergoing an MRI scan with an added 10-minute sequence, which may involve an injection. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.