Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parathyroid Adenoma Endocrine Gland Neoplasms Endocrine System Diseases F18-choline Head and Neck Neoplasms Hyperparathyroidism Neoplasms Neoplasms by Site Parathyroid Diseases Parathyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Brest, Brest, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MIBI scintigraphy

Diagnostic Test

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

Other names: F18-choline PET

F18-choline PET

Diagnostic Test

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

Other names: MIBI scintigraphy

Primary outcomes

  1. Compare, between each diagnostic strategy, the proportion of patients for whom the first-line imaging technique guided the surgical procedure wisely

    Time frame: Up to 2 months

Secondary outcomes

  1. Estimate the diagnostic performance of each strategy by measuring sensitivity and specificity

    Time frame: Up to 2 months

  2. Evaluate post-surgical complications by measuring tne number of infections, hematoma

    Time frame: Up to 2 months

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Collaborators

  • Fondation de l'Avenir

Registry information

Official study 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

Acronym: APACH2

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Aug 1, 2019
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.