Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647966
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Diagnostic Performance of 11CCholine PETCT In the Preoperative Assessment of Primary Hyperparathyroidism
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Diagnostic Performance of 11CCholine PETCT In the Preoperative Assessment of Primary Hyperparathyroidism
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary hyperparathyroidism HPT ranks as the third most common endocrine disorder characterized by excessive secretion of parathormone PTH a hormone crucial for regulating calcium and phosphorus metabolism within the body The only cure for HPT is surgically removing the hyperfunctioning parathyroid tissue both in symptomatic and asymptomatic settings With the advance of preoperative medical imaging techniques a paradigm shift has taken place in the surgical approach of this condition evolving from an inpatient bilateral cervical exploration to an outpatient minimally invasive procedure which has proved to be superior in outcome Due to the small size of the glands preoperative visualisation and localisation are mandatory for the surgeon Several imaging methods have been researched for identifying hyperfunctioning parathyroid glands including morphological functional and hybrid techniques with no clear agreement on the optimal imaging approachThe preoperative localization modalities available are ultrasonography parathyroid scintigraphy using technetium 99mTcTc sestamibi MIBI multiphase multidetector 4D computed tomography 4DCT magnetic resonance imaging and recently positron-emission tomographycomputed tomography PETCT using 11C- and 18F-labelled radiotracers While ultrasound and 99mTcTc-MIBI scintigraphy have been long used to diagnose and monitor patients with HPT they can lead to numerous false negative results and therefore require additional examinationsCholine PETCT is steadily replacing conventional imaging in many centres allowing for the localization of adenomas in three quarter of patients with negative previous imaging examinations but is still considered a relatively new method 11CC-Choline 11CCH PETCT is gradually gaining ground as a reliable method of localising HPT preoperatively due to its fast uptake in hyperfunctioning parathyroid tissue shorter acquisition time and lower radiation exposure compared to other nuclear medicine investigations and conventional methods 11CCH PETCT has been suggested to be superior in diagnostic performances compared to other imaging methods reaching sensitivities up to 989The aim of our retrospective single centre study is to evaluate the diagnostic performances and the inter-observer agreement of 11CCH PETCT for the preoperative detection of parathyroid adenomas in patients with suspected primary HPT
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None