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University of Wisconsin, MadisonUsing Novel Imaging to More Safely Treat Neuroendocrine Tumors
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06122610 untersucht Behandlung im Zusammenhang mit Neuroendokrine Tumoren, Somatostatinrezeptor-positiver neuroendokriner Tumor. Diese interventionsstudie der Phase 1 hat den Status offene rekrutierung und startete am 7. März 2025. Es ist geplant, 10 Teilnehmer aufzunehmen. Durchgeführt von University of Wisconsin, Madison wird der Abschluss für 1. Februar 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 13. Mai 2025 aktualisiert.
Kurzbeschreibung
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
Ausführliche Beschreibung
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.
Offizieller Titel
Dosimetry-Guided 177Lu-DOTATATE Treatment Planning Using 64Cu-DOTATATE as a Surrogate
Erkrankungen
Neuroendokrine TumorenSomatostatinrezeptor-positiver neuroendokriner TumorWeitere Studien-IDs
- 2023-0121
- Protocol Version 3/24/2025 (Andere Kennung) (UW Madison)
- SMPH/RADIOLOGY/RADIOLOGY (Andere Kennung) (UW Madison)
NCT-Nummer
Studienbeginn (tatsächlich)
2025-03-07
Zuletzt aktualisiert
2025-05-13
Studienende (vorauss.)
2026-02
Geplante Rekrutierung
10
Studientyp
Interventionsstudie
PHASE
Phase 1
Status
Offene Rekrutierung
Stichwörter
neuroendocrine tumors
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellParticipants 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 |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- 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
University of Wisconsin, Madison247 aktive klinische Studien zum ErkundenZentrale Studienkontakte
Kontakt: Radiology Studies, 608-282-8349, [email protected]
1 Studienstandorte in 1 Ländern
Wisconsin
University of Wisconsin - Madison, Madison, Wisconsin, 53705, United States
Offene Rekrutierung