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| Name | Class |
|---|---|
| Fondation de l'Avenir | OTHER |
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The investigators hypothesize that positron emission tomography with fluorocholline (F18-choline PET) will reduce the proportion of unnecessary invasive surgery decisions and that the higher cost of positron emission tomography versus MIBI scintigraphy (Tc99m-sestaMIBI ) will be offset by lower cost in terms of type. surgery performed wisely and complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEMP-TDM with MIBI | Other | Performing a MIBI scintigraphy, then, in the case of negativity, a F18-choline PET |
|
| F18-choline PET | Other | Realization of F18-choline PET, then, in case of negativity, a MIBI scintigraphy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIBI scintigraphy | Diagnostic Test | Performing a MIBI scintigraphy, then, in the case of negativity, a single F18-choline PET |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare, between each diagnostic strategy, the proportion of patients for whom the first-line imaging technique guided the surgical procedure wisely | Up to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate the diagnostic performance of each strategy by measuring sensitivity and specificity | Up to 2 months | |
| Evaluate post-surgical complications by measuring tne number of infections, hematoma | Up to 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brest | Brest | France | ||||
| Centre François Baclesse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38900416 | Derived | Quak E, Lasne-Cardon A, Cavarec M, Lireux B, Bastit V, Roudaut N, Salaun PY, Keromnes N, Potard G, Vaduva P, Esvant A, Jegoux F, de Crouy-Chanel O, Devillers A, Guery C, Lasnon C, Ciappuccini R, Legrand B, Estienne A, Christy F, Grellard JM, Bardet S, Clarisse B. F18-Choline PET/CT or MIBI SPECT/CT in the Surgical Management of Primary Hyperparathyroidism: A Diagnostic Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Aug 1;150(8):658-665. doi: 10.1001/jamaoto.2024.1421. | |
| 33413316 |
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Open, randomized, phase III study
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|
| F18-choline PET | Diagnostic Test | Realization of a F18-choline PET, then, in case of negativity, a MIBI scintigraphy |
|
|
| Caen |
| 14076 |
| France |
| Centre Eugène Marquis | Rennes | France |
| CHU | Rennes | France |
| Derived |
| Quak E, Lasne Cardon A, Ciappuccini R, Lasnon C, Bastit V, Le Henaff V, Lireux B, Foucras G, Jaudet C, Berchi C, Grellard JM, Lequesne J, Clarisse B, Bardet S. Upfront F18-choline PET/CT versus Tc99m-sestaMIBI SPECT/CT guided surgery in primary hyperparathyroidism: the randomized phase III diagnostic trial APACH2. BMC Endocr Disord. 2021 Jan 7;21(1):3. doi: 10.1186/s12902-020-00667-5. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 8, 2026 |
| ID | Term |
|---|---|
| D010282 | Parathyroid Neoplasms |
| D006961 | Hyperparathyroidism |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D010279 | Parathyroid Diseases |
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