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Recruiting NCT07632092

Early [18F]-FDG PET Dynamic Analysis in Brain Metastases After Radiotherapy.

Observational Short Time Examination Brain Metastases Radiation Necrosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CT scan.
Who it may be relevant to
Registry conditions: Short Time Examination, Brain Metastases, Radiation Necrosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Interest of Early Dynamic Analysis of [18F]-FDG PET Images in the Differential Diagnosis Between Recurrence and Radionecrosis in Brain Metastases.

Overview

Various treatment options are available for brain metastases, depending on factors such as lesion site or number lesions. Radiotherapy is a commonly used treatment. Following stereotactic radiotherapy for brain metastases, a potential complication, namely brain radionecrosis, can occur subsequently. It is essential to differentiate between this radionecrosis and lesion recurrence in order to determine the appropriate treatment approach. Contrast-enhanced magnetic resonance imaging (MRI) is the most widely used technique for monitoring brain metastases. Therefore, patients undergo routine MRI at 3 months and during subsequent follow-ups, but if the lesion evolve and if distinguishing between recurrence and radionecrosis is challenging, an \[18F\]-FDG PET scan is then prescribed by oncologists or radiotherapists during follow-up consultations. As part of the standard patient management protocol, a 10-minute image acquisition begins after a 45-60 minutes wait following the radiotracer injection. A second image acquisition is then conducted 3-4 hours later. For both acquisitions, a low-dose X-ray scanner is synchronously coupled to allow attenuation correction of the PET images. Patient for whom a \[18F\]-FDG PET cerebral examination has been prescribed as part of the usual management of brain metastases will be eligible to the protocol. If the patient agrees to participate, an early imaging session is initiated immediately upon radiotracer injection, lasting 15 minutes in addition to the standard acquisition protocol.

Interventions

  • Other CT scan
    The patient is installed in the PET camera as soon as he is injected, so that early fixation of the \[18F\]-FDG radiotracer can be recorded for 15 minutes. As part of this acquisition, a CT scan dedicated for attenuation correction is also performed. Both this scan and the late scan will be carried out at ultra--low dose so that the total dose received by the patient does not exceed what he would have received without this research. The patient's total examination time remains unchanged

Primary outcome measures

  • ratio between lesion maximum activity and controlateral healthy tissue activity [Time frame: day1]
Secondary outcome measures (1)
  • association between kinetic uptake parameters and diagnosis [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Patient referred for cerebral \[18F\]-FDG PET examination prescribed as part of his usual medical care for brain metastasis.
  • Age ≥ 18 years old
  • Affiliation to a social security program
  • Ability of the subject to understand and express his consent

Exclusion criteria

  • Age under 18 years old
  • Person under guardianship or curatorship
  • Pregnant or breastfeeding woman
  • Primary brain tumors
  • Brain metastases from renal, thyroid or other cancers known to have low avidity for \[18F\]-FDG

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • CHRU Amiens — Amiens

Identifiers

NCT: NCT07632092 · PI2026_843_0020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗