To assess the diagnostic performance (sensitivity, specificity, ROC curve) of the bone SPECT/CT scans. To assess the intra- and interobserver variability of SPECT/CT in patients suspected of having UCH.
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the sensitivity and specificity of the bone SPECT/CT
scan compared to the sensitivity and specificity of the SPECT scan in patients
with a suspected UCH. To provide a receiver operating characteristics (ROC)
curve in order to select the optimal diagnostic method (SPECT/SPECT-CT).
Secondary outcome
The second endpoint of this study is the inter-observer and intra-observer
agreement for the SPECT/CT scanning in patients with a suspected UCH
Background summary
SPECT/CT is a hybrid imaging technique which combines anatomical computed
tomography (CT) and functional scintigraphic imaging. The fusion of form (CT)
and function (SPECT) greatly improves the diagnostic information obtainable
from using either technique alone. The hypothesis of this study is that
SPECT/CT imaging will improve the diagnostic accuracy for unilateral condylar
hyperactivity over conventional SPECT imaging.
Study objective
To assess the diagnostic performance (sensitivity, specificity, ROC curve) of
the bone SPECT/CT scans. To assess the intra- and interobserver variability of
SPECT/CT in patients suspected of having UCH.
Study design
Prospective clinical diagnostic study. Patient with a mandibular asymmetry
suspected to have UCH receive a bone SPECT/CT to determine if there is an
active growing condyle. The original SPECT data can be extracted out of the
SPECT/CT images. The results of clinical follow-up or surgery and histology of
the specimen are compared to the initial SPECT and SPECT/CT results.
Study burden and risks
this study adds a low dose CT to the SPECT scan which increases the radiation
dose to the patient. In the case of UCH it is appropriate to limit the CT field
of view to the condylar region to minimize the additional radiation. The
outcome of this study is of great importance for the future diagnostic and
treatment strategy for patients with a mandibular asymmetry. SPECT/CT can be
used to optimize the treatment strategy and to prevent unnecessary surgical
procedures or unnecessary clinical progression of the disease.
Boelelaan 1117
AMsterdam 1081 HV
NL
Boelelaan 1117
AMsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
-progressive facial asymmetry with mandible involvement
Exclusion criteria
-facial asymmetry suspected to be based on a non-UCH cause
-apparent temporomandibular joint disorder
-apparent systemic or local bone disease
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 | NL39426.029.13 |