NCT04040946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2019

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 19, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

2.6 years

First QC Date

July 29, 2019

Last Update Submit

July 31, 2023

Conditions

Parathyroid AdenomaHyperparathyroidismF18-choline

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

TEMP-TDM with MIBI

OTHER

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

Diagnostic Test: MIBI scintigraphyDiagnostic Test: F18-choline PET

F18-choline PET

OTHER

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

Diagnostic Test: MIBI scintigraphyDiagnostic Test: F18-choline PET

Interventions

MIBI scintigraphyDIAGNOSTIC_TEST

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

Also known as: F18-choline PET
F18-choline PETTEMP-TDM with MIBI
F18-choline PETDIAGNOSTIC_TEST

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

Also known as: MIBI scintigraphy
F18-choline PETTEMP-TDM with MIBI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU Brest

Brest, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Centre Eugène Marquis

Rennes, France

Location

CHU

Rennes, France

Location

Related Publications (2)

  • Quak E, Lasne-Cardon A, Cavarec M, Lireux B, Bastit V, Roudaut N, Salaun PY, Keromnes N, Potard G, Vaduva P, Esvant A, Jegoux F, de Crouy-Chanel O, Devillers A, Guery C, Lasnon C, Ciappuccini R, Legrand B, Estienne A, Christy F, Grellard JM, Bardet S, Clarisse B. F18-Choline PET/CT or MIBI SPECT/CT in the Surgical Management of Primary Hyperparathyroidism: A Diagnostic Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Aug 1;150(8):658-665. doi: 10.1001/jamaoto.2024.1421.

    PMID: 38900416DERIVED

  • 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.

    PMID: 33413316DERIVED

MeSH Terms

Conditions

Parathyroid NeoplasmsHyperparathyroidism

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesParathyroid Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Open, randomized, phase III study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2019

First Posted

August 1, 2019

Study Start

September 19, 2019

Primary Completion

May 5, 2022

Study Completion

June 30, 2023

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations

FR(4)