This is an exploratory study, but we expect to find that the apparent diffusion coefficient on diffusion-weighted MRI and SUVmax on FDG-PET are able to differentiate between tumor tissue and treatment effects.
ID
Bron
Verkorte titel
Aandoening
Laryngeal and hypopharyngeal carcinoma
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Value of various imaging parameters at tumorous and non-tumorous tissue.
Achtergrond van het onderzoek
This prospective study aims to find imaging variables that can help differentiate recurrent laryngeal or hypopharyngeal tumor tissue from tissue that has been affected by radiation.
Patients with recurrent laryngeal or hypopharyngeal cancer after radiotherapy that are scheduled for a laryngectomy will be included. Pre-surgery MRI, CT and FDG-PET imaging will be compared with whole-mount histology. The tumor outline, as determined on the pathology, can be transferred to the various in vivo imaging. Different imaging parameters will be tested for their ability to differentiate tumor tissue from treatment effects.
Doel van het onderzoek
This is an exploratory study, but we expect to find that the apparent diffusion coefficient on diffusion-weighted MRI and SUVmax on FDG-PET are able to differentiate between tumor tissue and treatment effects.
Onderzoeksopzet
There are no set time points for the measurements. There is a maximum of 20 days between imaging (MRI, CT and FDG-PET) and total laryngectomy. The laryngectomy specimen immediately fixated in 4% formaldahyde, so the pathology is preserved for the comparison with the imaging.
As for the secondary outcome, delineation guidelines will be prepared based on the primary outcomes. Radiologist will be asked to delineate the tumor on the imaging of the first 10 patients. Afterwards, they will be asked to delineate the second set of 10 patients while following the delineation guidelines. Overlap between radiologists' delineation with and without guidelines, and the tumor outline as determined on the pathology will determine whether or not the guidelines improved the delineation.
Onderzoeksproduct en/of interventie
Not applicable
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Recurrent laryngeal or hypopharyngeal carcinoma after radiotherapy with or without chemotherapy and scheduled for a salvage total laryngectomy. Over the age of 18. Given informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Contraindication for MRI at 3T and/or CT contrast administration. Insulin dependent diabetes mellitus.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL9110 |
Ander register | METC UMCU : 20-617 |