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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04040946
Other study ID # APACH2
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 19, 2019
Est. completion date June 30, 2023

Study information

Verified date July 2023
Source Centre Francois Baclesse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date June 30, 2023
Est. primary completion date May 5, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

Diagnostic Test:
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

Locations

Country Name City State
France CHU Brest Brest
France Centre François Baclesse Caen
France Centre Eugène Marquis Rennes
France CHU Rennes

Sponsors (2)

Lead Sponsor Collaborator
Centre Francois Baclesse Fondation de l'Avenir

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compare, between each diagnostic strategy, the proportion of patients for whom the first-line imaging technique guided the surgical procedure wisely Up to 2 months
Secondary Estimate the diagnostic performance of each strategy by measuring sensitivity and specificity Up to 2 months
Secondary Evaluate post-surgical complications by measuring tne number of infections, hematoma Up to 2 months
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