E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Preoperative localisation of hyperfunctioning parathyroid tissue in suspected primary hyperparathyroidism. |
Præoperativ lokalisationsdiagnostik af hyperfungerende parathyroideavæv mistænkt primær hyperparathyroidisme. |
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E.1.1.1 | Medical condition in easily understood language |
Preoperative localisation of hyperfunctioning parathyroid tissue in suspected primary hyperparathyroidism. |
Præoperativ lokalisationsdiagnostik af hyperfungerende parathyroideavæv mistænkt primær hyperparathyroidisme. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036693 |
E.1.2 | Term | Primary hyperparathyroidism |
E.1.2 | System Organ Class | 100000004860 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
MET-PET-Studiet - Sammenlignende studie af Tc-99m-sestamibi SPECT/ldCT med C-11-L-Methionin PET/diagnostisk CT mht deres evne til præoperativ lokalisationsdiagnostik af hyperfungerende parathyroideavæv ved mistænkt primær hyperparathyridisme. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
Mænd og kvinder over 18 år som er henvist til vores afdeling mhp lokalisationsdiagnostik af hyperfungerende parathyroideavæv forud for planlagt operation for mistænkt primær hyperparathyroidisme. |
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E.4 | Principal 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. |
Mistænkt sekundær og tertiær hyperparathyroidisme. Mistænkt Familiær Hypercalciurisk Hypercalcæmi. Mistænkt Familiær Hyperparathyroidisme. Mistænkt Multiple Endokrin Neoplasi. Patienter i behandling med Litium and / or Mimpara. Graviditet. Kendt allergi overfor tracerne der infunderes. Kendt allergi overfor iodholdige kontrastmidler Personer 18 år eller yngre. Tidligere operation eller radioterapi mod halsen. Hvis parathyroideascintigrafien aflyses eller der er mere end 14 dage mellem de to undersøgelser. Hvis patienten er blevet opereret mellem de to undersøgelser. Hvis patienten ikke bliver opereret indenfor 12 måned efter at have gennemført de to undersøgelser. Inhabilitet - hvis personen ikke taler og forstår dansk i tilstrækkelig grad til at medvirke, eller har kognitive problemer som hindrer aktiv medvirken. Manglende eller tilbagetrukket samtykke. |
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E.5 End points |
E.5.1 | 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.
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PET/diagnostisk-CT. Golden standard er peroperative lokalisationsfund og PTH-målinger, kombineret med histopatologiske fund. Hver undersøgelse evalueres af mindst to læger i rutinen, som alle har erfaring med beskrivelse af undersøgelserne og hvoraf mindst en er speciallæge og ligeledes af en speciallæge i radiologi ved bedømmelse af den diagnostiske CT. Undersøgelserne beskrives blindet i forhold til den anden undersøgelse, men ikke overfor andre billedmodaliteter. Tilslut udformes et samlet svar for undersøgelserne til henvisende afdeling, men først når hver undersøgelse er færdigevalueret for angivne endepunkter. Evalueringen Sammenlignende studie af Tc-99m-sestamibi SPECT/ld-CT og C-11-L-Methionin for hver undersøgelse består af en visuel bedømmelse mht detektion og lokalisation af hyperfungerende parathyroideavæv ved mistænkt primær hyperparathyroidisme i rutinen. Evalueringen bygger på følgende parametre. Primære endepunkter: Detektion af hyperfungerende parathyroideavæv og evaluering af detektionssikkerheden bedømt ud fra fem kategorier; 1. Sikkert adenom 2. Forementlig adenom 3. I tvivl 4. Formentlig negativ 5. Sikkert negativ.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Evaluation of the imaging results is performed continuously. |
Evaluering af undersøgelsesresultaterne foregår kontinuert. |
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E.5.2 | 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. |
Sekundære endepunkter: - Lokalisering af hyperfungerende parathyroideavæv, ved markering på en fantomtegning, opdels i 11 regioner; 1. Højre kranielt 2. Højre centralt 3.Højre kaudalt 4.Venstre kranielt 5. Venstre centralt 6.Venstre kaudalt 7. Istmus 8. Ektopisk caput 9. Ektopisk collum 10. Ektopisk Thorax 11. Intet adenom påvist. - Sikkerheden hvormed denne lokalisering kan angives eller ikke angives, anført på en skala 1-5. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Evaluation of the imaging results is performed continuously. |
Evaluering af undersøgelsesresultaterne foregår kontinuert. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |