To study the value of MRI and 18FDG-PET-CT in the detection of local residual oropharyngeal disease after chemoradiation to avoid futile routine examination under general anesthesia.
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is accuracy with which diagnostic tests reduce the number
of avoided futile EUAs.
Secondary outcome
Secondary endpoints are interobserver agreement, SUV (FDG-PET) and ADC (DW-MRI)
thresholds, associated costs and burden of diagnostic procedures and health
related quality of life.
Background summary
Current clinical practice is to perform response evaluation, i.e. examination
under general anesthesia (EUA), routinely at 3 months after the end of
treatment in patients who underwent chemoradiation for oropharyngeal cancer.
Due the high response rates more than half of the patients are exposed to
unnecessary biopsies. Biopsies in previously irradiated areas may induce
complaints, e.g. pain, inflammation, wound healing problems, swallowing,
dyspnea. Biopsies in previously treated areas may be false negative due to
sampling errors within the residual mass. Besides aforementioned burden to the
patient, such a examination under general anesthesia (EUA) requires hospital
stay and operating facilities.
Study objective
To study the value of MRI and 18FDG-PET-CT in the detection of local residual
oropharyngeal disease after chemoradiation to avoid futile routine examination
under general anesthesia.
Study design
Prospective observational non-randomized multicenter study.
MRI, 18FDG-PET-CT and (routinely performed) examinations under general
anesthesia (EUA) pretreatment and 3 months after chemoradiation.
Study burden and risks
In current clinical practice most of these patients would already undergo
imaging (MRI and/or PET) pre-treatment 3 months after treatment. Radiation
exposure due to repeated PET scanning is very low as compared to the radiation
therapy of these patients. These patients may already benefit from PET and MRI
due to improved diagnostic pretreatment and guidance (for eventual biopsy)
during examination under general anesthesia. In the future patients may benefit
from MRI and/or PET 3 months after chemoradiation to select reliably for
examination under general anesthesia. Improved imaging may be helpful in
diagnosing residual disease and avoiding futile examinations under general
anesthesia.
De Boelelaan 1117
1081 HV
NL
De Boelelaan 1117
1081 HV
NL
Listed location countries
Age
Inclusion criteria
*Oropharyngeal squamous cell carcinoma
*Initially resectable
*Scheduled for chemoradiation
Exclusion criteria
*Pregnancy
*Physical condition contra-indication salvage surgery
*Contra-indication for MRI (i.e. claustrofobia)
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 | NL39181.029.12 |