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Lo studio clinico NCT06122610 per Tumori Neuroendocrini, Tumore neuroendocrino positivo al recettore della somatostatina 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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Università del Wisconsin-MadisonUsing Novel Imaging to More Safely Treat Neuroendocrine Tumors
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT06122610 è uno studio interventistico di Fase I volto a esaminare il trattamento per Tumori Neuroendocrini, Tumore neuroendocrino positivo al recettore della somatostatina, attualmente in arruolamento. Avviato il 7 marzo 2025, prevede di arruolare 10 partecipanti. Sotto la guida di l'Università del Wisconsin-Madison, dovrebbe concludersi entro il 1 febbraio 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 13 maggio 2025.
Sommario breve
The goal of this research is to determine if DetectnetTM PET/CT can be used to make Lutathera therapy safer for patients with neuroendocrine cancer.
Participants will:
- Complete two phases involving 6 visits
- Undergo additional research PET/CT, and possibly SPECT/CT scans
Descrizione dettagliata
The goal of this research study is to determine if DetectnetTM PET/CT scanning over several days can be used to deliver Lutathera in a safer manner.
In this research, participants will be asked to complete a screening phase and possibly a dosimetry phase. The screening phase will require 2 visits. The dosimetry phase will also require 3 research visits.
Titolo ufficiale
Dosimetry-Guided 177Lu-DOTATATE Treatment Planning Using 64Cu-DOTATATE as a Surrogate
Condizioni
Tumori NeuroendocriniTumore neuroendocrino positivo al recettore della somatostatinaAltri ID dello studio
- 2023-0121
- Protocol Version 3/24/2025 (Altro identificativo) (UW Madison)
- SMPH/RADIOLOGY/RADIOLOGY (Altro identificativo) (UW Madison)
Numero NCT
Data di inizio (effettiva)
2025-03-07
Ultimo aggiornamento pubblicato
2025-05-13
Data di completamento (stimata)
2026-02
Arruolamento (previsto)
10
Tipo di studio
Interventistico
FASE
Fase I
Stato
In arruolamento
Parole chiave
neuroendocrine tumors
Scopo principale
Trattamento
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleParticipants treated with Lutathera | Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT) SPECT/CT will be performed after first cycle of Lutathera® treatment Photon Emission Tomography / CT (PET/CT) PET/CT will be performed after 64Cu-DOTATATE and Lutathera® treatment 64Cu-Dotatate Standard of care administration of radioactive drug for PET/CT 177Lu-Dotatate Standard of care administration of radioactive drug for PET/CT and SPECT/CT |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Compare pre-therapy and post-therapy voxel-based dosimetry estimates | Absorbed doses to organs will be estimated using radiation dosimetry methods based on both multi-timepoint PET and multi-timepoint SPECT imaging. Mean dose estimates in units of Gy to the index tumor(s) and dose limiting organs (kidneys and bone marrow) will be compared between PET-based dosimetry and SPECT-based dosimetry. Using SPECT-based dosimetry as the gold standard truth, Bland-Altman analysis will be performed for each organ/tumor to compare PET-based dose estimates to SPECT-based estimates. Mean bias and 95% confidence intervals will be calculated. | Baseline and 120 hours post-dose |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Absorbed radiation doses | Absorbed radiation doses from 177Lu-DOTATATE in organs will be summarized with descriptive statistics. | 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose |
Absorbed radiation doses of 64Cu-DOTATATE | Absorbed radiation doses of 177Lu-DOTATATE in organs using 64Cu-DOTATATE as an imagining surrogate will be summarized with descriptive statistics. | 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose |
Compare 3D voxel-based versus model based dosimetry in participants receiving 177Lu_DOTATATE | Absorbed doses to organs will be estimated using radiation dosimetry methods based on multi-timepoint SPECT imaging. Mean dose estimates in units of Gy to the index tumor(s) and dose limiting organs (kidneys and bone marrow) will be compared between 3D voxel-based and model-based dosimetry methods. Using 3D voxel-based dosimetry as the gold standard truth, Bland-Altman analysis will be performed for each organ/tumor to compare 3D voxel-based to model-based methods. Mean bias and 95% confidence intervals will be calculated. | Baseline and 120 hours post-dose |
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Candidates for 177Lu-DOTATATE (Lutathera) treatment for somatostatin receptor-positive neuroendocrine tumor
- Unable to lie flat during or tolerate PET/CT or SPECT/CT
- Known incompatibility to CT. SPECT, or PET scans
- Unlikely to comply with study procedures, restrictions and requirements and judged by the investigator that the participant is not suitable for participation in the study
Università del Wisconsin-Madison247 studi clinici attivi da esplorareContatti principali dello studio
Contatto: Radiology Studies, 608-282-8349, [email protected]
1 Centri dello studio in 1 paesi
Wisconsin
University of Wisconsin - Madison, Madison, Wisconsin, 53705, United States
In arruolamento