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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)

C

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

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)

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

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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