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 (APACH2)

Centre Francois Baclesse

Status and phase: Completed; Phase 3

Conditions: F18-choline; Hyperparathyroidism; Parathyroid Adenoma

Treatments: Diagnostic Test: F18-choline PET; Diagnostic Test: MIBI scintigraphy

Study type: Interventional

Funder types: Other

Identifiers

NCT04040946

APACH2

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

TEMP-TDM with MIBI

Other group

Description:

Performing a MIBI scintigraphy, then, in the case of negativity, a F18-choline PET

Treatment:

Diagnostic Test: MIBI scintigraphy

Diagnostic Test: F18-choline PET

F18-choline PET

Other group

Description:

Realization of F18-choline PET, then, in case of negativity, a MIBI scintigraphy

Treatment:

Diagnostic Test: MIBI scintigraphy

Diagnostic Test: F18-choline PET