The hypothesis is that FDG-PET/MRI is more accurate than FDG-PET/CT for re-staging after nCRT.
ID
Bron
Verkorte titel
Aandoening
Locally advanced esophageal adenocarcinoma or squamous cell carcinoma
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary study parameter is qualitative re-staging after nCRT based on FDG-PET/MRI versus FDG-PET/CT, with pathology as gold standard (i.e. histopathologic assessment of the resection specimen when patients undergo surgery after nCRT, or histopathology/cytopathology of the primary tumor and suspected (distant) metastases as obtained during standard follow-up when patients do not undergo surgery or postpone surgery after nCRT).
Achtergrond van het onderzoek
FDG-PET/MRI is a new technique that combines simultaneous acquisition of an 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) scan with a magnetic resonance imaging (MRI) scan. FDG-PET/MRI has the potential to provide better anatomical visualization compared to FDG-PET/computed tomography (FDG-PET/CT), which is the current standard functional imaging modality used for staging esophageal cancer. In addition, FDG-PET/MRI has the possibility to provide functional information through MRI-specific parameters that quantify cellular density in tissue, which has been shown relevant for tumor detection. However, the potential utility of FDG-PET/MRI for response evaluation after neoadjuvant chemoradiotherapy (nCRT) to facilitate and improve personalized treatment yet needs to be determined. The aim of the study is to evaluate the feasibility of FDG-PET/MRI to improve tumor response assessment after nCRT compared to standard FDG-PET/CT.
Doel van het onderzoek
The hypothesis is that FDG-PET/MRI is more accurate than FDG-PET/CT for re-staging after nCRT.
Onderzoeksopzet
One time point, the extra study scan takes place at the response evaluation after nCRT.
Onderzoeksproduct en/of interventie
Patients receive treatment according to standard clinical care during the conduct of the study. Patients who participate in this study will undergo one FDG-PET/MRI scan in total, planned sequentially to a clinically indicated (preoperative) FDG-PET/CT after completion of nCRT.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age ≥18 years;
- Histologically proven esophageal adenocarcinoma or squamous cell carcinoma located caudally to the carina;
- Completed neoadjuvant chemoradiotherapy (nCRT);
- Scheduled to undergo FDG-PET/CT at 4-6 weeks after nCRT or at 8-12 weeks after nCRT.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Contra-indications for MRI (e.g. pacemaker, metal implant, claustrophobia);
- Contra-indications for iodinated contrast media (e.g. previous contrast-allergy or eGFR <30 ml/min/1,73m2);
- FDG-non avid tumor as determined from the pre-treatment PET/CT scan;
- Incapacitated patients, prohibiting the understanding and giving of informed consent and to complete the questionnaire on experienced burden with PET/MRI.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9352 |
| CCMO | NL75204.078.20 |
| OMON | NL-OMON50029 |