FDG-PET/CT vs. CT for Monitoring Metastatic Breast Cancer
A legfontosabb adatok
- Hol
- Aalborg, Aarhus, Copenhagen Oe, Esbjerg, Herlev, Odense C, Soenderborg és Vejle (Dánia)Mind a 8 helyszín megnézése
- Fázis
- 3. fázis
AI-kivonat: kiket keres a vizsgálat
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat olyan felnőtteket keres, akiknél nemrég áttétes mellrákot diagnosztizáltak, és akik hamarosan elkezdik az első vonalbeli gyógyszeres kezelést. A kontrollt FDG-PET/CT vizsgálattal, illetve CT vizsgálattal hasonlítják össze.
- Életkor
- 18 éves vagy idősebb
- Nem
- Nők és férfiak is részt vehetnek.
- A betegség stádiuma
- Távoli áttétet adó mellrák, amely kiújult (biopsziával igazolva), vagy eleve áttétes volt (de novo). De novo esetben az elsődleges daganat biopsziája és a távoli áttétre jellemző képalkotó lelet is kell.
- Korábbi kezelés
- Kaphat első vonalbeli szisztémás kezelést, és részt vehet rendszeres képalkotó kontrollon. A kezelés megkezdődhet a biopszia eredménye előtt, ha a biopsziát elvégezték vagy tervezik.
A részvétel fő kizáró okai
- Terhes vagy szoptató nők
- Másik daganat miatti folyamatban lévő kezelés
- Kizárólag agyi áttét
- FDG-allergia
- Nem olvassa és nem érti a megkövetelt nyelvet (Dániában dán, Olaszországban olasz vagy angol, Németországban német vagy angol)
Gépi kiolvasás: 2026. november 9.
Helyszínek itt: Dánia
- Aalborg University HospitalAalborg, DániaRésztvevőt keres
- Aarhus UniversitetAarhus, DániaRésztvevőt keres
- RigshospitaletCopenhagen Oe, DániaRésztvevőt keres
- Esbjerg Og Grindsted SygehusEsbjerg, DániaRésztvevőt keres
- Copenhagen University HospitalHerlev, DániaRésztvevőt keres
- Odense University HospitalOdense C, DániaRésztvevőt keres
- Sygehus Soenderjylland SoenderborgSoenderborg, DániaRésztvevőt keres
- Lillebaelt HospitalVejle, DániaRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Odense University Hospital
- Azonosító
- NCT06877949EU 2023-508591-11-00
- A regiszteradat frissítve
- 2026. február 20.
- Eredeti leírás
Several studies have shown improved sensitivity of FDG-PET/CT compared with conventional imaging for diagnosing metastatic breast cancer in retrospective and smaller prospective studies. For response monitoring, we expect FDG-PET/CT to detect disease progression earlier than CT in patients treated for metastatic breast cancer, enabling earlier start of second-line therapies.A teljes eredeti leírásKevesebb
FDG-PET/CT Versus Conventional CT for Response Monitoring in Metastatic Breast Cancer: A Multicenter Randomized Clinical Trial (MONITOR-RCT)
Several studies have shown improved sensitivity of FDG-PET/CT compared with conventional imaging for diagnosing metastatic breast cancer in retrospective and smaller prospective studies. For response monitoring, we expect FDG-PET/CT to detect disease progression earlier than CT in patients treated for metastatic breast cancer, enabling earlier start of second-line therapies.
Current knowledge about the potential benefit of FDG-PET/CT for response monitoring of patients with metastatic breast cancer comes from observational studies. Consequently, current evidence is only hypothesis-generating and prospective, randomized trials such as the MONITOR-RCT are needed to corroborate these findings.
The MONITOR-RCT clinical trial aims to investigate whether monitoring with FDG-PET/CT can improve survival in patients diagnosed with metastatic breast cancer. It is a parallel group comparative randomized trial comparing an experimental monitoring strategy based on FDG-PET/CT with a standard monitoring strategy based on CT.
Participating patients should have newly diagnosed metastatic breast cancer and be considered eligible for initiating first-line medical treatment and subsequent regular response monitoring. A total of 420 patients will be included in the study, with recruitment taking place across 11 participating hospital sites in Denmark, Germany, and Italy.
The main questions it aims to answer are:
* Can monitoring with FDG-PET/CT compared to conventional CT prolong the overall survival of MBC patients? * Is this-as expected-due to earlier detection of disease progression and earlier initiation of second-line therapies? * Is this accompanied by less need for additional diagnostics, less need for hospitalization, and improved quality of life?
Participants will:
* Undergo FDG-PET/CT scans at scheduled intervals to monitor disease progression. * Be given standard treatments as part of oncological care, which is informed by the FDG-PET/CT scans * Fill out questionnaires about their quality of life at various time points throughout the study.
Objectives are:
Primary: To demonstrate superiority in overall survival of response monitoring with FDG-PET/CT in patients with metastatic breast cancer over response monitoring based on CT. Appropriately adapted PERCIST criteria for FDG-PET/CT and the RECIST1.1 criteria for CT will be used.
Secondary: To demonstrate superiority in quality of life and exposure to oncologic treatment with FDG-PET/CT and to investigate the cost-effectiveness.
Bevonási feltételek: Women and men aged ≥18 years; Diagnosis of distant relapsed MBC (biopsy-verified) or de novo breast cancer. In patients with distant relapsed MBC, biopsy verification from a distant metastasis is required. In patients with de novo MBC, biopsy verification of primary tumor and diagnostic imaging with distant metastasis with a typical pattern of MBC is required; Considered eligible for first-line systemic treatment; Considered eligible for continuous treatment monitoring by scans; Signed informed consent; Participants must have the ability to read and understand the following languages based on their country of participation: in Denmark, patients must be able to read and understand Danish; in Italy, they must be able to read and understand Italian or English; and in Germany, they must be able to read and understand German or English; In case of patients for whom it is necessary to start first-line systemic treatment while still waiting for the evaluation of the biopsy, it is allowed to include the patients, as long as the other criteria are fulfilled and the biopsy is made or planned. In case verification by biopsy fails, the patients will leave the trial (cf. 4c). We expect that up to 3% of the patients included will start first-line systemic treatment prior to evaluation of the biopsy.
Kizáró feltételek: Ongoing oncological treatment for another cancer; Allergy to FDG; Pregnant or lactating women; Exclusively brain metastasis.