Clinical trial NCT04040946: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parathyroid Adenoma
Hyperparathyroidism
F18-choline
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: Fondation de l'Avenir
First posted: 2019-08-01
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open, randomized, phase III study
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Compare, between each diagnostic strategy, the proportion of patients for whom the first-line imaging technique guided the surgical procedure wisely
timeFrame: Up to 2 months
Secondary outcomes:
measure: Estimate the diagnostic performance of each strategy by measuring sensitivity and specificity
timeFrame: Up to 2 months
measure: Evaluate post-surgical complications by measuring tne number of infections, hematoma
timeFrame: Up to 2 months
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
city: Caen
country: France
facility: Centre François Baclesse
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rennes
country: France
facility: CHU
Study officials:
References:
citation: 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.