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

Hyperparathyroidism Clinical Trial

— APACH2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04040946
• Other study ID #: APACH2
• Status: Completed
• Phase: Phase 3
• 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
• 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)

Related Conditions & MeSH terms

• Adenoma
• F18-choline
• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Parathyroid Adenoma
• Parathyroid Neoplasms

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