To study the value of whole body MRI in screening on distant metastases in HNSCC patients with high risk factors.
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints are the proportion of clinically relevant findings (detection
of distant metastases) with MRI and/or PET/CT and the diagnostic accuracy of
MRI, PET/CT and combination of MRI and PET/CT.
Secondary outcome
Secondary endpoint is the interobserver agreement of MRI and PET/CT.
Background summary
The detection of distant metastases in head and neck squamous cell carcinoma
(HNSCC) patients can avoid futile extensive treatments. In routine clinical
practice HNSCC patients with high risk factors for distant metastases undergo
pretreatment screening on distant metastases by FDG-PET/CT. However, follow-up
reveals that a substantial percentage of distant metastases are missed.
Therefore, room for improvement remains. Due to the introduction of
multi-receiver channel MR, whole body MRI (WB-MRI) has become clinically
feasible and shows promising results for the detection of distant metastases in
other solid tumours.
Study objective
To study the value of whole body MRI in screening on distant metastases in
HNSCC patients with high risk factors.
Study design
This is a prospective observational non-randomized single-institute pilot study
of 20 consecutive patients.
All patients will undergo pretreatment whole body FDG-PET/CT and whole body MRI
in random order as dictated by logistics.
accuracy of both diagnostic techniques will be determined and compared.
Study burden and risks
In current clinical practice these patients undergo FDG-PET/CT pretreatment.
Whole body MRI may potentially detect additional distant metastases. Radiation
exposure of PET/CT is very low as compared to the radiation therapy which
almost all of these patients will undergo. In this study no adverse or serious
adverse events are expected, since FDG-PET/CT and MRI scans are used in common
daily practice for this indication. Patients may benefit, because futile
extensive treatments will be avoided if any distant metastases are detected.
De Boelelaan 1117
1081 HV
NL
De Boelelaan 1117
1081 HV
NL
Listed location countries
Age
Inclusion criteria
head and neck cancer
high risk factors for distant metastases
candidate for extensive locoregional treatment with curative intent
Exclusion criteria
known with distant metastases (no screening)
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 | NL27603.029.09 |