The primary objective of our study is to investigate the performance of FCH-PET as a second-line imaging modality for localizing hyper-functioning parathyroid gland(s) in patients with biochemically proven PHP for whom surgery is indicated, thereby…
ID
Source
Brief title
Condition
- Parathyroid gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome of the study is the performance of FCH PET/CT in localizing
the pathological parathyroid gland(s) defined as PPV and sensitivity. This will
be controlled by surgically removing the suspicious gland(s). If post-operative
normalisation of the ICa level is found, surgery is considered successful.
Therefore the endpoint of our study will be a normal blood hormone level of ICa
one week after surgery.
Secondary outcome
NA
Background summary
Conventional pre-operative imaging in patients with primary hyperparathyroidism
(PHP) includes neck ultrasound and Tc-99m-sestamibi SPECT/CT. When findings of
conventional imaging are concordant patients undergo surgery with a minimally
invasive approach (MIA). In 30 - 50 % of patients one of the imaging modalities
is negative or the imaging is discordant. These patients cannot undergo MIA and
the operation is either postponed or more extensive with neck exploration where
all parathyroid glands have to be investigated.
18Fluor-choline (FCH) is a promising new PET tracer and there are reports that
FCH has superior sensitivity for the detection of hyper functioning parathyroid
glands. With the addition of FCH PET/CT we hope to optimize preoperative
work-up allowing for MIA in patients with PHP.
Study objective
The primary objective of our study is to investigate the performance of FCH-PET
as a second-line imaging modality for localizing hyper-functioning parathyroid
gland(s) in patients with biochemically proven PHP for whom surgery is
indicated, thereby making them eligible for MIA. Only patients with negative
SPECT/CT will be included.
Study design
Prospective diagnostic study investigating the accuracy of FCH PET/CT in
localizing the hyper-functioning parathyroid gland(s).
Study burden and risks
Patients participating in the study with negative findings on conventional
imaging will undergo additional FCH PET/CT imaging. The results of FCH PET/CT
will be used for the pre-operative work-up of the patients thereby potentially
allowing MIA.
The proposed study is considered safe and well tolerable. The risks of the
extra FCH PET/CT are negligible and the benefits could possibly be MIA instead
of more extensive surgical neck exploration.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Patients who have signed informed consent;- Age >= 18 years;- Biochemically proven PHP;- Indication for surgery;- Negative SPECT/CT
Exclusion criteria
- Pregnancy ;- Patients with MEN syndrome
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2014-004590-16-NL |
| CCMO | NL47508.041.14 |