A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning. (ADVANCE-MCD)
A Post Approval Single-arm Study Evaluating Transarterial Radioembolization Treatment for Hepatocellular Carcinoma Using Multicompartment Dosimetry Planning
The purpose of this study is to assess the safety and effectiveness of treating a tumor using a different planning method called MCD for the FDA-Approved device, TheraSphere.
TheraSphere Microspheres are microscopic radioactive glass spheres that deliver radiation therapy in the liver tissue where they are placed. This study investigates a procedure called multicompartment dosimetry (MCD). When using a multicompartment dosimetry approach, the doctor will look at images of the liver to see where there is tumor to determine where to treat. That area will be divided into "compartments" where the dose to tumor and the healthy liver are calculated separately. The goal of MCD is to give the tumor a higher radiation dose while protecting more of the healthy part of the liver.
Traditional planning for the TheraSphere Microspheres procedure uses single compartment dosimetry (SCD) which treats the tumor and the healthy liver as one area so the dose is more evenly distributed and the dose to the tumor may be lower than with the MCD approach. The single compartment approach is standard and is well established however this research study is to see if giving TheraSphere Microspheres with an MCD planning method is safe and effective by evaluating the effect of radiation on the liver as well as how the tumor responds to higher doses
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Natalie Lydon, MHA
- Telefonnummer: +1 (612) 240-6364
- E-Mail: natalie.lydon@bsci.com
Studieren Sie die Kontaktsicherung
- Name: Krista Asmus, MPH
- Telefonnummer: +1 (952) 356-9553
- E-Mail: krista.asmus@bsci.com
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- TheraSphere Microspheres treatment determined as the optimal therapy
- Have unresectable solitary HCC
- Treatment Naïve
- ECOG 0 or 1
- Adequate liver function
- Adequate renal and marrow function
- Negative pregnancy test and/or adequate contraception for the patient and his/her sexual partner
Exclusion Criteria:
- Macrovascular invasion
- Extrahepatic metastases
- Previous or current ascites/encephalopathy
- Previous liver radiation, TACE, or systemic therapy for the disease
- History of organ allograft including bone marrow
- Any significant comorbities or contraindications to TheraSphere
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Unresectable Hepatocellular Carcinoma
Patients with unresectable hepatocellular carcinoma (HCC) with tumor sizes 1-8cm.
Patients will be candidates for TheraSphere Microspheres and planning to undergo the procedure as part of their treatment plan.
|
Placement of TheraSphere Microspheres into the area of the primary tumor using multicompartment dosimetry instead of single compartment dosimetry
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Primary Safety Endpoint
Zeitfenster: 4 months
|
The rate of Radioembolization Induced Liver Disease (REILD) Grade ≥3 occurring up to 4 months after any TheraSphere Microspheres treatment administration before progression.
|
4 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Secondary Safety Endpoint
Zeitfenster: 13 months
|
Number of device- and/or procedure-related adverse events (AEs) and serious adverse events (SAEs), measured by count (number of events).
|
13 months
|
|
Secondary Safety Endpoint
Zeitfenster: 13 months
|
Change from baseline in Albumin Bilirubin (ALBI) score, measured using the ALBI index.
|
13 months
|
|
Secondary Safety Endpoint
Zeitfenster: 13 months
|
Most severe grade of hepatotoxicity following radioembolization, assessed using CTCAE grading criteria.
|
13 months
|
|
Secondary Effectiveness Endpoint
Zeitfenster: 13 months
|
Objective Response Rate (ORR) as assessed by localized mRECIST criteria.
|
13 months
|
|
Secondary Effectiveness Endpoint
Zeitfenster: 13 months
|
Duration of Response (DoR) evaluated by localized mRECIST and mRECIST criteria.
|
13 months
|
|
Secondary Effectiveness Endpoint
Zeitfenster: 13 months
|
Number of patients who become eligible for liver transplantation or liver resection following treatment, measured by total count (number of patients).
|
13 months
|
|
Secondary Effectiveness Endpoint
Zeitfenster: 13 months
|
Histopathologic response assessment in patients who undergo surgical resection, collected through descriptive and categorial data points.
|
13 months
|
|
Secondary Effectiveness Endpoint
Zeitfenster: 13 months
|
Overall Survival (OS), defined as the time from treatment initiation to death from any cause, measured in months.
|
13 months
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- S10104
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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