ClinicalTrials.gg
CompletedNCT04040946APACH2Updated Aug 1, 2023

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

A Phase 3 interventional study of MIBI scintigraphy and F18-choline PET in Parathyroid Adenoma, Hyperparathyroidism and F18-choline, sponsored by Centre Francois Baclesse. Completed at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-01.

Sponsored by Centre Francois Baclesse · Phase 3, Interventional, and Diagnostic

Phase
Phase 3
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Parathyroid Adenoma
  • Hyperparathyroidism
  • F18-choline
03

In context

Parathyroid Neoplasms

63 studies on the registry are indexed under Parathyroid Neoplasms; 19 are open to participants now.

This study's enrollment of 59 is close to the median of 60 across 38 interventional studies indexed under Parathyroid Neoplasms.

Browse Parathyroid Neoplasms studies →

Lead sponsor

Centre Francois Baclesse is the lead sponsor of 110 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patient deprived of liberty, under tutorship or curatorship
  • 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 (sodium chloride, water for injections)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • Other
    TEMP-TDM with MIBI

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

    Diagnostic Test: MIBI scintigraphy · Diagnostic Test: F18-choline PET

  • Other
    F18-choline PET

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

    Diagnostic Test: MIBI scintigraphy · Diagnostic Test: F18-choline PET

Interventions

  • Diagnostic testMIBI scintigraphy

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

    Also known as: F18-choline PET

  • Diagnostic testF18-choline PET

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

    Also known as: MIBI scintigraphy

06

What researchers measure

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

07

Study locations

4 sites
  • CHU Brest
    Brest, France
  • Centre François Baclesse
    Caen, 14076, France
  • Centre Eugène Marquis
    Rennes, France
  • CHU
    Rennes, France
08

References and documents

Publications

  • Quak E, Lasne Cardon A, Ciappuccini R, Lasnon C, Bastit V, Le Henaff V, Lireux B, Foucras G, Jaudet C, Berchi C, Grellard JM, Lequesne J, Clarisse B, Bardet S. Upfront F18-choline PET/CT versus Tc99m-sestaMIBI SPECT/CT guided surgery in primary hyperparathyroidism: the randomized phase III diagnostic trial APACH2. BMC Endocr Disord. 2021 Jan 7;21(1):3. doi: 10.1186/s12902-020-00667-5. PubMed 33413316 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04040946
Collaborators
Fondation de l'Avenir
Responsible party
Sponsor
First posted
Aug 1, 2019
Start date
Sep 19, 2019
Primary completion
May 5, 2022
Completion
Jun 30, 2023
Last update
Aug 1, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion