Preoperative localisation of hyperfunctioning parathyroid tissue in suspected primary hyperparathyroidism. MedDRA version: 19.1 Level: LLT Classification code 10036693 Term: Primary hyperparathyroidism System Organ Class: 100000004860
Conditions
Interventions
Trade Name: Stamicis
Product Name: N/A
Pharmaceutical Form: Infusion
INN or Proposed INN: TECHNETIUM (99MTC) SESTAMIBI
CAS Number: 109581-73-9
Current Sponsor code: Technetium-99m-methoxyisobutylisoni
Sponsors
Dep. Nuclear medicine, Odense university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women above the age of 18 years who are referred to our department for preoperative localisation of hyperfunctioning parathyroid tissue prior to operation for suspected primary hyperparathyroidism. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Suspected secondary and tertiary hyperparathyroidism. Suspected Familiar hypocalciuria hypercalcemia. Suspected Familiar Hyperparathyroidism. Suspected multiple endocrine neoplasia (MEN) Patients treated with Lithium and / or Mimpara Pregnancy. Known allergy to the tracers infused. Known allergy to iodine containing contrast agents. Persons 18 years or younger. Former operation / radiotherapy towards the neck. If the prathyroidscintigraphy is cancelled or there is more than a forthnight between the two examniations. If the patient has undergone operation between the two examinations. If the patient is not operated within 12 months after completing the two examinations. Inhability - if the person does not speak and understand danish to a degree acceptable to participate or has cognitive problems that complicates active participation. If there is no signed consent to participate or the concent has been withdrawn.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: MET-PET-study - Comparative study of Tc-99m- sestamibi SPECT/ldCT with C-11-L-Methionine PET/diagnostic CT and their ability to locate hyerpunctioning paratyroid tissue preoperatively in suspected primary hyperparathyroidism.;Secondary Objective: N/A;Primary end point(s): Comparison of Tc-99m-sestamibi SPECT/ld-CT to C-11-L-Methionin PET/diagnostic-CT. Golden standard being peroperative findings of localisation and PTH-measurements, combined with histopathological findings. The evaluation of each examination is conducted by at least two M.D's, who carry out the daily description of such examinations and with at least one having senior nuclear medicine expertise and an exsperienced radiologist in regard to description of diagnostic CT. Each is blinded to the other set of images but not to other imaging modalities. Ultimately a consensus-based description of each patient is made after the evaluation of each examination is complete. The consensus-based description is consistent with answers given to the referring party. The evaluations are based on visual assessments regarding detection and localisation of hyperfunctioning parathyroid tissue in suspected primary hyperparathyroidism in relation to routine descriptions of the examinations. The basis of the evaluation is comprised of the following parameter; Primary endpoint: Detection of hyperfunctioning parathyroid tissue and evaluation of level of certainty in this detection divided into five categories. 1.Certain pathology 2. Predominantly certain pathology 3. Intermediate risk of pathology 4. Predominantly no pathology 5. No pathology. ;Timepoint(s) of evaluation of this end point: Evaluation of the imaging results is performed continuously. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: - Localisation of hyperfunctioning parathyroid tissue, by marking on a phantomdrawing, divided into 11 regions; 1.Right kraniel 2. Right central 3. Right kaudal 4. Left kraniel 5.Left central 6.Left kaudal 7.Istmus 8. Ectopic caput 9. Ectopic collum 10. Ectopic Thorax 11. No adenoma - The certainty by which the localisation can be pointed out or not - specified on a scale 1-5.;Timepoint(s) of evaluation of this end point: Evaluation of the imaging results is performed continuously. | — |
Countries
Denmark
Contacts
Public Contactsys.vestergaard@rsyd.dk
Dep.nuclear medicine, Odense university hospital
Outcome results
None listed