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NCT Number: NCT07632092

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Amiens

Amiens, France

Location status: Recruiting

Location contact

Alexandre COUTTE, MD

SUB_INVESTIGATOR

Antoine GIRARD, MD

CONTACT

[email protected]

33+3 22 45 03 81

Chalabia FERGANI, MD

SUB_INVESTIGATOR

Florent Hives, MD

SUB_INVESTIGATOR

Ismaël NEJJAR, MD

SUB_INVESTIGATOR

Marc-Etienne MEYER, Pr

SUB_INVESTIGATOR

Mathieu BOONE, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT scan

Other

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 outcomes

  1. ratio between lesion maximum activity and controlateral healthy tissue activity

    Time frame: day1

    Value of the measurement of the ratio of the maximum activity within the lesion to the average activity within the region of interest of the contralateral healthy tissue.

Secondary outcomes

  1. association between kinetic uptake parameters and diagnosis

    Time frame: 12 months

    association between kinetic uptake parameters from compartmental models and the differential diagnosis of radionecrosis and recurrence of brain metastases treated by radiotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine GIRARD

CONTACT

[email protected]

33+3 22 45 03 81

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: DYNFDGTEP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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