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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04040946

Acronym

APACH2

Enrollment

Registered

2019-08-01

Start date

2019-09-19

Completion date

2023-06-30

Last updated

2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F18-choline, Hyperparathyroidism, Parathyroid Adenoma

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.

Interventions

DIAGNOSTIC_TESTMIBI scintigraphy

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

DIAGNOSTIC_TESTF18-choline PET

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Open, randomized, phase III study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Estimate the diagnostic performance of each strategy by measuring sensitivity and specificity	Up to 2 months
Evaluate post-surgical complications by measuring tne number of infections, hematoma	Up to 2 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026