Trial Comparing 2 Diagnostic Strategies for Preoperative Localization of Parathyroid Adenoma in Primary Hyperparathyroidism:TEMP / CT With Tc99m-sestaMIBI or PET / CT With F18-choline in First Intention
NCT ID: NCT04040946
Last Updated: 2023-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
59 participants
INTERVENTIONAL
2019-09-19
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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TEMP-TDM with MIBI
Performing a MIBI scintigraphy, then, in the case of negativity, a F18-choline PET
MIBI scintigraphy
Performing a MIBI scintigraphy, then, in the case of negativity, a single F18-choline PET
F18-choline PET
Realization of a F18-choline PET, then, in case of negativity, a MIBI scintigraphy
F18-choline PET
Realization of F18-choline PET, then, in case of negativity, a MIBI scintigraphy
MIBI scintigraphy
Performing a MIBI scintigraphy, then, in the case of negativity, a single F18-choline PET
F18-choline PET
Realization of a F18-choline PET, then, in case of negativity, a MIBI scintigraphy
Interventions
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MIBI scintigraphy
Performing a MIBI scintigraphy, then, in the case of negativity, a single F18-choline PET
F18-choline PET
Realization of a F18-choline PET, then, in case of negativity, a MIBI scintigraphy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient presenting with primary hyperparathyroidism and for whom an excisional surgery is planned
* For women of childbearing age, negative pregnancy test at Baseline
* Biological assessment confirming the diagnosis of primary hyperparathyroidism (high serum PTH and calcium concentrations)
* Affiliation to a social security scheme
* Patient having signed his written consent
Exclusion Criteria
* Hypersensitivity to TECNESCAN SESTAMIBI
* Any associated medical or psychological condition that could compromise the patient's ability to participate in the study
* Pregnant or lactating woman
* History of parathyroid surgery
* Patient with multiple endocrine neoplasia 1 (NEM1)
* Known hypersensitivity to fluorocholine or to any of the excipients (sodium chloride, water for injections)
18 Years
ALL
No
Sponsors
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Fondation de l'Avenir
OTHER
Centre Francois Baclesse
OTHER
Responsible Party
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Locations
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CHU Brest
Brest, , France
Centre François Baclesse
Caen, , France
Centre Eugène Marquis
Rennes, , France
CHU
Rennes, , France
Countries
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References
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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.
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.
Other Identifiers
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APACH2
Identifier Type: -
Identifier Source: org_study_id
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