Phase III trial comparing 2 diagnostic strategies for the 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 the preoperative localization of parathyroid adenoma in primary hyperparathyroidism: TEMP / CT with Tc99m-sestaMIBI or PET / CT with F18-choline in first intention - APACH2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000274-36-FR

Enrollment

Registered

2019-04-02

Start date

2019-07-03

Completion date

Unknown

Last updated

2023-10-03

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

Conditions

Patient with primary hyperparathyroidism and for which surgical resection is provided. MedDRA version: 20.0 Level: PT Classification code 10020705 Term: Hyperparathyroidism System Organ Class: 10014698 - Endocrine disorders

Interventions

Trade Name: Fluorochol Product Name: Fluorocholine (18F) Pharmaceutical Form: Radiopharmaceutical precursor, solution INN or Proposed INN: Fluorochol Current Sponsor code: 18 Fluorocholine Other descr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patient over 18 years of age - Patient with primary hyperparathyroidism for whom excisional surgery is planned - Biological assessment confirming the diagnosis of primary hyperparathyroidism (high serum PTH and calcium concentrations) - Affiliation to a social security system - Patient who has signed his written consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 58 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 58

Exclusion criteria

Exclusion criteria: - Patient deprived of liberty, under guardianship 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 breastfeeding woman - History of parathyroid surgery - Patient with Multiple Endocrine Neoplasia 1 (MEN1)

Design outcomes

Primary

Measure	Time frame
Main Objective: Compare, between each diagnostic strategy, the proportion of patients for whom the first-line imaging technique (SPECT/CTD at MIBI or PET/CT at FCH) has guided the surgical procedure appropriately (decision of true positive minimally invasive surgery and patient recovery);Secondary Objective: - Carry out a medico-economic evaluation comparing the costs and effectiveness of the two diagnostic strategies - Estimate the diagnostic performance of each strategy - Evaluate the number of parathyroid surgery failures at 6 months (regardless of the type of surgery performed) for each strategy - Evaluate post-surgical complications - Evaluate intra- and inter-observer variability for the interpretation of PET-MT at FCH and SPECT-MT at MIBI - Explore the relationship between the positivity of imaging tests, including PET/CT to FCH and serum PTH concentration at inclusion - Evaluate the detection performance of PET-TDM at FCH over an early imaging time of 10 min post-injection compared to the acquisition performance at 60 min. ;Primary end point(s): Proportion of patients for whom the first-line imaging technique (SPECT/CTD at MIBI or PET/CTD at FCH) has been successful in guiding the surgical procedure appropriately as defined by: - a decision to perform positive (and appropriate) true minimally invasive surgery AND - the patient's recovery, defined by normalization of blood calcium and PTH at one month and 6 months post-surgery;Timepoint(s) of evaluation of this end point: After surgery	—

Measure

Time frame

Main Objective: Compare, between each diagnostic strategy, the proportion of patients for whom the first-line imaging technique (SPECT/CTD at MIBI or PET/CT at FCH) has guided the surgical procedure appropriately (decision of true positive minimally invasive surgery and patient recovery);Secondary Objective: - Carry out a medico-economic evaluation comparing the costs and effectiveness of the two diagnostic strategies - Estimate the diagnostic performance of each strategy - Evaluate the number of parathyroid surgery failures at 6 months (regardless of the type of surgery performed) for each strategy - Evaluate post-surgical complications - Evaluate intra- and inter-observer variability for the interpretation of PET-MT at FCH and SPECT-MT at MIBI - Explore the relationship between the positivity of imaging tests, including PET/CT to FCH and serum PTH concentration at inclusion - Evaluate the detection performance of PET-TDM at FCH over an early imaging time of 10 min post-injection compared to the acquisition performance at 60 min. ;Primary end point(s): Proportion of patients for whom the first-line imaging technique (SPECT/CTD at MIBI or PET/CTD at FCH) has been successful in guiding the surgical procedure appropriately as defined by: - a decision to perform positive (and appropriate) true minimally invasive surgery AND - the patient's recovery, defined by normalization of blood calcium and PTH at one month and 6 months post-surgery;Timepoint(s) of evaluation of this end point: After surgery

—

Secondary

Measure	Time frame
Secondary end point(s): - Average cost of managing a patient for each of the two strategies - Sensitivity, specificity, error rates, positive and negative likelihood ratios of PET/CT to FCH and SPECT/CT to MIBI - Rates of minimally invasive surgery and bilateral cervical explorations for each diagnostic strategy - Number of parathyroid surgery failures (regardless of the type of surgery performed), defined by the persistence of primary hyperparathyroidism 6 months after surgery - Complications occurring within one month of surgery: infections, haematomas, laryngeal recurrent nerve damage - Cohen's kappa coefficients between the 2 independent readers, at their first reading, then at their second reading (3 months later); as well as between the first and second readings of each of the 2 readers - Serum PTH concentration at inclusion - Compare the detection sensitivities of PET-DMT to FCH at 10 min and 60 min post-injection, as well as the semi-quantitative analysis.;Timepoint(s) of evaluation of this end point: After surgery	—

Measure

Time frame

Secondary end point(s): - Average cost of managing a patient for each of the two strategies - Sensitivity, specificity, error rates, positive and negative likelihood ratios of PET/CT to FCH and SPECT/CT to MIBI - Rates of minimally invasive surgery and bilateral cervical explorations for each diagnostic strategy - Number of parathyroid surgery failures (regardless of the type of surgery performed), defined by the persistence of primary hyperparathyroidism 6 months after surgery - Complications occurring within one month of surgery: infections, haematomas, laryngeal recurrent nerve damage - Cohen's kappa coefficients between the 2 independent readers, at their first reading, then at their second reading (3 months later); as well as between the first and second readings of each of the 2 readers - Serum PTH concentration at inclusion - Compare the detection sensitivities of PET-DMT to FCH at 10 min and 60 min post-injection, as well as the semi-quantitative analysis.;Timepoint(s) of evaluation of this end point: After surgery

—

Countries

France

Contacts

Public ContactElisabeth QUAK

Centre François Baclesse

e.quak@baclesse.unicancer.fr33231455002

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026