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Contribution of the CEST Sequence in the Characterization of Radionecrosis of Brain Metastases of Pulmonary Origin (ACROP)

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ClinicalTrials.gov Identifier: NCT05977803
Recruitment Status : Recruiting
First Posted : August 4, 2023
Last Update Posted : April 9, 2024
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Brain Metastases Radionecrosis Pulmonary Cancer Radiation: MRI with CEST sequence, IVIM and ASL sequence Not Applicable

Detailed Description:

Brain metastases are frequent secondary sites in the evolution of cancers, with an incidence of all cancers combined of about 20% and up to 40% in the later phases of the disease. Among these metastases, the lung is the most common primary lesion (responsible for 20-56% of brain metastases). The overall prognosis for metastatic brain cancers is poor, with treatment-free survival of 1 to 2 months, and with treatment averaging 7-8 months. Their treatment is based on systemic medical treatment (chemotherapy, immunotherapy or targeted therapy depending on the status of the lesion) and on the other hand on the response to local treatment (surgery or radiotherapy). Radiotherapy is performed either as a first-line or post-operative depending on the resectability of the lesions and the operability of the patient.

Radionecrosis is a late complication (6 months to 2 years on average) and frequent (5-25%) of stereotactic radiotherapy. It may be promoted by the concomitant use of immunotherapy such as checkpoint inhibitors, which implies a probable increase in its incidence. Treatment of radionecrosis is based on corticosteroids; recent studies also propose Bevacizumab.

The distinction in MRI between tumor progression and radionecrosis is based on a multimodal approach. Indeed, conventional sequences alone have average performance (sensitivity 76% and specificity 59%). Several MRI methods have been evaluated, but their performance varies according to the studies. Cerebral perfusion is the most widely used method, requiring contrast injection with correct performance. However, there is no standardized perfusion value to directly extrapolate these results. MRI spectroscopy has also been studied, with correct performance but only evaluated on weak samples and retrospectively.

CEST is an MRI technique that uses endogenous contrast, i.e. does not require injection of contrast medium. It consists of specifically altering the signal of a molecular compound by causing saturation (i.e. cancellation of its signal) and studying the saturation of the solute (i.e. water) on contact. Indeed, due to a process called 'chemical saturation transfer', the signal from the water in contact with the targeted compound will also become partially saturated. The subtraction of the MRI signals acquired before and after saturation makes it possible to obtain a tissue mapping of the molecular compound initially targeted obtaining an indirect reflection of its concentration. Indeed, the macromolecular composition of tissues (inaccessible for physical reasons in spectroscopy) differs according to radionecrosis status or tumor progression, with more ""amide"" compounds in the second case.

This relatively recent development technique has been studied in primary and secondary brain tumors, especially in the context of radionecrosis, but mainly in primary brain tumors. It seems to allow a more precise and earlier detection of possible tumor progressions.

The diagnosis of radionecrosis is therefore a major step forward for the management of patients with irradiated brain metastases.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Contribution of the CEST Sequence in the Characterization of Radionecrosis of Brain Metastases of Pulmonary Origin
Actual Study Start Date : February 15, 2024
Estimated Primary Completion Date : February 15, 2026
Estimated Study Completion Date : February 15, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Radiation therapy
Patient treated for metastatic cerebral lung cancer who has been treated with external beam radiotherapy such as in toto brain irradiation or stereotactic radiosurgery followed in the thoracic oncology department of Bichat Hospital.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 24 months ]
    Diagnostic performance of the CEST sequence in the diagnosis of radionecrosis on irradiated metastases of primary lung cancer compared to injected T2* infusion sequence


Secondary Outcome Measures :
  1. Diagnostic performances for the IVIM sequence using IVIM scattering derivatives: f', ADC [ Time Frame: 24 months ]
  2. Diagnostic performances for the ASL (arterial spin labeling) sequence using ASL infusion derivatives: intralesional CBF (cerebral blood flow) relative to contralateral white matter CBF [ Time Frame: 24 months ]
  3. 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. [ Time Frame: 24 months ]
  4. Diagnostic performances of coupled CEST, IVIM and ASL sequences, evaluated by the derivates of the IVIM scattering : f', ADC [ Time Frame: 24 months ]
  5. 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 [ Time Frame: 24 months ]
  6. Tolerance of acquisition of all CEST, IVIM and ASL sequences evaluated by the percentage of exams interrupted. [ Time Frame: 24 months ]
  7. Describtion of non-tumor white matter changes in the irradiation field and outside the CEST sequence irradiation field during follow-up [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05977803


Contacts
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Contact: Augustin Gaudemer, MD 01 40 25 76 13 augustin.gaudemer@aphp.fr
Contact: Marie-Cécile Henry-Feugeas, MD 01 40 25 81 52 marie-cecile.henry-feugeas@aphp.fr

Locations
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France
Hôpital Bichat-Claude Bernard Recruiting
Paris, France, 75018
Contact: Augustin Gaudemer, MD    01 40 25 76 13    augustin.gaudemer@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Augustin Gaudemer, MD Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT05977803    
Other Study ID Numbers: APHP230263
First Posted: August 4, 2023    Key Record Dates
Last Update Posted: April 9, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
radionecrosis, metastases,
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Lung Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
 Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases