No registrations found.
ID
Source
Brief title
Health condition
Laryngeal and hypopharyngeal carcinoma
Sponsors and support
Intervention
Outcome measures
Primary outcome
Value of various imaging parameters at tumorous and non-tumorous tissue.
Secondary outcome
Improvement of radiologists' ability to delineate tumor with the outcomes of this study.
Background summary
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.
Study objective
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.
Study design
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.
Intervention
Not applicable
Inclusion criteria
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.
Exclusion criteria
Contraindication for MRI at 3T and/or CT contrast administration. Insulin dependent diabetes mellitus.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL9110 |
Other | METC UMCU : 20-617 |