- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07632092
Early [18F]-FDG PET Dynamic Analysis in Brain Metastases After Radiotherapy. (DYNFDGTEP)
Interest of Early Dynamic Analysis of [18F]-FDG PET Images in the Differential Diagnosis Between Recurrence and Radionecrosis in Brain Metastases.
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Antoine GIRARD
- Telefonnummer: 33+3 22 45 03 81
- E-post: Girard.Antoine@chu-amiens.fr
Studiesteder
-
-
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Amiens, Frankrike
- Rekruttering
- CHRU Amiens
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Underetterforsker:
- Alexandre COUTTE, MD
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Underetterforsker:
- Mathieu BOONE, MD
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Ta kontakt med:
- Antoine GIRARD, MD
- Telefonnummer: 33+3 22 45 03 81
- E-post: Girard.Antoine@chu-amiens.fr
-
Underetterforsker:
- Ismaël NEJJAR, MD
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Underetterforsker:
- Marc-Etienne MEYER, Pr
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Underetterforsker:
- Chalabia FERGANI, MD
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Underetterforsker:
- Florent Hives, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
ratio between lesion maximum activity and controlateral healthy tissue activity
Tidsramme: 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.
|
day1
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
association between kinetic uptake parameters and diagnosis
Tidsramme: 12 months
|
association between kinetic uptake parameters from compartmental models and the differential diagnosis of radionecrosis and recurrence of brain metastases treated by radiotherapy
|
12 months
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PI2026_843_0020
Plan for individuelle deltakerdata (IPD)
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