Clinical trial · Interventional
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
Phase III 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
NCT04040946CI-TRIAL-00068393APACH2completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| F18-choline | — | UNRESOLVED | — |
| Hyperparathyroidism | — | UNRESOLVED | — |
| Parathyroid Adenoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| F18-choline PET | Diagnostic Test | — | UNRESOLVED |
| MIBI scintigraphy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- TEMP-TDM with MIBI
- description
- Performing a MIBI scintigraphy, then, in the case of negativity, a F18-choline PET
- interventionNames
- Diagnostic Test: MIBI scintigraphy
- Diagnostic Test: F18-choline PET
- type
- OTHER
- label
- F18-choline PET
- description
- Realization of F18-choline PET, then, in case of negativity, a MIBI scintigraphy
- interventionNames
- Diagnostic Test: MIBI scintigraphy
- Diagnostic Test: F18-choline PET
Primary outcomes (1)
- measure
- Compare, between each diagnostic strategy, the proportion of patients for whom the first-line imaging technique guided the surgical procedure wisely
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient 18 years old * 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: * Patient deprived of liberty, under tutorship or curatorship * 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)
References
Publications (2)
- DERIVEDQuak 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. PMID 38900416
- DERIVEDQuak 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. PMID 33413316