Trial Radar IA | ||
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Lo studio clinico NCT07339085 per Neoplasia Maligna del Cervello, Neoplasia Maligna Metastatica nel Cervello è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Advanced Magnetic Resonance Imaging for the Identification of Recurrent Brain Tumors and Radiation Necrosis 42
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La sperimentazione clinica NCT07339085 è uno studio interventistico per Neoplasia Maligna del Cervello, Neoplasia Maligna Metastatica nel Cervello, attualmente in arruolamento. Avviato il 28 agosto 2025, prevede di arruolare 42 partecipanti. Sotto la guida di Jonsson Comprehensive Cancer Center, dovrebbe concludersi entro il 30 luglio 2030. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 15 gennaio 2026.
Sommario breve
This clinical trial studies whether advanced magnetic resonance imaging (MRI) techniques, including diffusion-relaxation correlation spectrum imaging (DR-CSI) and sodium imaging, can be used to identify the difference between brain tumors that come back after a period of improvement (recurrent) and treatment-related tissue damage (radiation necrosis \[RN\]). Radiation therapy is often used in the treatment of brain t...Mostra di più
Descrizione dettagliata
PRIMARY OBJECTIVES:
I. Develop and validate dual-nuclei microstructural MRI biomarkers to differentiate between recurrent brain metastasis (rBM) and RN.
II. Investigate longitudinal microstructural changes following stereotactic radiosurgery (SRS) treatment and predict clinical outcome.
OUTLINE: Patients are assigned to 1 of 2 aims.
AIM 1: Patients undergo advanced DR-CSI and sodium MRI over 30 minutes prior to s...
Mostra di piùTitolo ufficiale
Advanced Dual-Nuclei MRI for Differentiation of Recurrent Brain Metastases and Radiation Necrosis
Patologie
Neoplasia Maligna del CervelloNeoplasia Maligna Metastatica nel CervelloAltri ID dello studio
- 25-1250
- NCI-2025-06605 (Identificativo del registro) (CTRP (Clinical Trial Reporting Program))
- 25-1250 (Altro identificativo) (UCLA / Jonsson Comprehensive Cancer Center)
- P30CA016042 (Sovvenzione/Contratto NIH (USA))
- R21CA303383 (Sovvenzione/Contratto NIH (USA))
Numero NCT
Data di inizio (effettiva)
2025-08-28
Ultimo aggiornamento pubblicato
2026-01-15
Data di completamento (stimata)
2030-07-30
Arruolamento (previsto)
42
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Scopo principale
Diagnostico
Allocazione
Non randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleAim 1 (advanced MRI) Patients undergo advanced DR-CSI and sodium MRI over 30 minutes prior to SOC surgical resection or biopsy. Patients also undergo clinical MRI and tissue sample collection on study. | Advanced Magnetic Resonance Imaging Undergo advanced DR-CSI and sodium MRI Raccolta di biospecimen Undergo tissue sample collection Imaging a risonanza magnetica Undergo clinical MRI |
SperimentaleAim 2 (advanced MRI) Patients undergo advanced DR-CSI and sodium MRI over 30 minutes before SRS and 2 weeks, 3 months, and 6 months post-SRS. Patients also undergo clinical MRI on study. | Advanced Magnetic Resonance Imaging Undergo advanced DR-CSI and sodium MRI Imaging a risonanza magnetica Undergo clinical MRI |
Esito primario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Imaging features of recurrent brain metastasis (rBM) and radiation necrosis (RN) (Aim 1) | Will compute the diffusion-relaxation (DR) spectra and total sodium concentration (TSC) within biopsy regions of interest and use Student t-test or Mann-Whitney U test, depending on the data distribution, to compare imaging features between rBM and RN groups. Specifically, for DR spectra, the test statistic at each spectral location will be used to identify spectral components associated viable tumor and treatment effect. The information will subsequently be used to partition the voxel-wise DR spectra and compute voxel-wise "viable tumor" and "treatment effect" fraction maps. Multivariate logistic regression models will assess the predictive value of the imaging biomarkers, including DR-correlation spectrum imaging (CSI) spectral components and TSC. Receiver operating characteristic (ROC) analysis will evaluate diagnostic performance, calculating area under the curve, sensitivity, specificity, and optimal cutoff values for differentiating rBM and RN. | At time of advanced magnetic resonance imaging: Baseline |
Stereotacic imaging-guided biopsies and correlation with tissue quantifications (Aim 1) | Will prospectively acquire DR-CSI and sodium imaging-guided biopsies of tumor tissue in regions with different imaging characteristics. Pearson or Spearman correlations will be computed between imaging features and quantitative histological measures of cellularity, extracellular fraction, and percentages of tumor and necrosis. | Up to completion of surgery |
Early imaging changes as predictors of clinical outcomes (Aim 2) | Will compute DR-CSI spectral components and TSC at each time point. Repeated measure analysis of variance will assess imaging changes over time. Will also plot trajectories of imaging biomarkers to visualize temporal patterns. Multivariate logistic regression models will evaluate early imaging changes (2 weeks and 3 months) as predictors of 6-month outcomes. Lesions will be stratified into responders (complete or partial response) and non-responders (stable disease or progression) based on their Response Assessment in Neuro-Oncology Brain Metastases assessment at 6-month post-SRS. ROC curves will assess the predictive performance of early microstructural imaging changes and the multivariate model. Primary tumor type will be included as a covariate in analyses. | At baseline and 2 weeks, 3 months, and 6 months post-stereotactic radiosurgery (SRS) |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Age > 18 years old
- Diagnosed with metastatic brain tumor
- AIM 1: Scheduled for surgical resection or tissue biopsy +/- laser interstitial thermal therapy (LITT)
- AIM 2: Scheduled for SRS treatment
- Patients with contraindications to MRI, severe renal impairment
- Patients with evidence of disseminated leptomeningeal disease
Nessun dato di contatto
1 Centri dello studio in 1 paesi
California
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, 90095, United States
Jingwen Yao, Contatto, 310-869-2156, [email protected]
Jingwen Yao, Investigatore principale
In arruolamento