To identify imaging features that can differentiate recurrent laryngeal or hypopharyngeal cancer from treatment effects after radiotherapy based on whole mount histology as reference
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The accuracy of DCE- and DWI-MRI based parameters based parameters in the
differentiation of recurrent tumor tissue and radiation induced changes
Secondary outcome
Improvement of radiologists* delineation of tumor recurrences on imaging when
given the results of this study.
The accuracy of FDG-PET and CT based parameters in the differentiation of
recurrent tumor tissue and radiation induced changes.
Background summary
Early detection of recurrent laryngeal or hypopharyngeal carcinoma is crucial
to improve patient prognoses. However, differentiating between post radiation
treatment effects and recurrent or residual tumoral tissue is still very
challenging; on imaging, recurrences are often hidden by radiation effects like
edema, fibrosis or inflammation, and biopsies can give false negatives due to
sampling errors.
In order to not overlook recurrences and minimize the number of unnecessary
biopsies, we want to be able to accurately recognize tumors with imaging alone.
This study aims to contribute to that goal
Study objective
To identify imaging features that can differentiate recurrent laryngeal or
hypopharyngeal cancer from treatment effects after radiotherapy based on whole
mount histology as reference
Study design
This study is a descriptive, diagnostic study that will compare imaging with
whole mount histologic specimens of laryngeal and hypopharyngeal recurrences.
Study burden and risks
In the normal clinical procedure patients will undergo a DCE- and DW-MRI,
sometimes supplemented with an FDGPET/CT. All imaging procedures before the
total laryngectomy will be performed in a radiotherapy mask. If the MR and/or
the CT scan is not available, too old (>20 days) or of insufficient quality for
study purposes, or if the MRI is older than 20 days, patients will be asked to
undergo additional imaging. This ensures that all patients receive a CT and MRI
scan prior to treatment. If an additional CT scan is needed, patients will be
exposed to radiation due to study participation.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Recurrent laryngeal or hypopharyngeal carcinoma after primary radiotherapy
- Scheduled for salvage total laryngectomy
- >=18 years of age
- Given informed consent
Exclusion criteria
- Patients who meet exclusion criteria for MRI at 3T as defined in the
protocols of the radiology department
- Patients with contraindication for CT contrast administration as defined in
the protocols of the radiology department
Design
Recruitment
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 |
|---|---|
| CCMO | NL74949.041.20 |