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APACH2: 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

Sponsor
Centre Francois Baclesse (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04040946
Collaborator
Fondation de l'Avenir (Other)
58
Enrollment
4
Locations
2
Arms
41.4
Anticipated Duration (Months)
14.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: MIBI scintigraphy
  • Diagnostic Test: F18-choline PET
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Open, randomized, phase III studyOpen, randomized, phase III study
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official 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
Actual Study Start Date :
Sep 19, 2019
Actual Primary Completion Date :
May 5, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: TEMP-TDM with MIBI

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

Diagnostic Test: MIBI scintigraphy
Performing a MIBI scintigraphy, then, in the case of negativity, a single F18-choline PET
Other Names:
  • F18-choline PET

    • Diagnostic Test: F18-choline PET
    Realization of a F18-choline PET, then, in case of negativity, a MIBI scintigraphy
    Other Names:
  • MIBI scintigraphy

    		•
    Other: F18-choline PET

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

    Diagnostic Test: MIBI scintigraphy
    Performing a MIBI scintigraphy, then, in the case of negativity, a single F18-choline PET
    Other Names:
  • F18-choline PET

    • Diagnostic Test: F18-choline PET
    Realization of a F18-choline PET, then, in case of negativity, a MIBI scintigraphy
    Other Names:
  • MIBI scintigraphy

    		•

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. Estimate the diagnostic performance of each strategy by measuring sensitivity and specificity [Up to 2 months]

    2. Evaluate post-surgical complications by measuring tne number of infections, hematoma [Up to 2 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Brest Brest France
    2 Centre François Baclesse Caen France 14076
    3 Centre Eugène Marquis Rennes France
    4 CHU Rennes France

    Sponsors and Collaborators

    • Centre Francois Baclesse
    • Fondation de l'Avenir

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Francois Baclesse
    ClinicalTrials.gov Identifier:
    NCT04040946
    Other Study ID Numbers:
    • APACH2
    First Posted:
    Aug 1, 2019
    Last Update Posted:
    May 9, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Adenoma
    Parathyroid Neoplasms
    Hyperparathyroidism
    Hyperparathyroidism, Primary
    Choline

    Study Results

    No Results Posted as of May 9, 2022