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 (APACH2)

July 31, 2023 updated by: Centre Francois Baclesse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France
        • Chu Brest
      • Caen, France, 14076
        • Centre François Baclesse
      • Rennes, France
        • Centre Eugène Marquis
      • Rennes, France
        • CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Estimate the diagnostic performance of each strategy by measuring sensitivity and specificity
Time Frame: Up to 2 months
Up to 2 months
Evaluate post-surgical complications by measuring tne number of infections, hematoma
Time Frame: Up to 2 months
Up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Collaborators

Fondation de l'Avenir

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2019

Primary Completion (Actual)

May 5, 2022

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

July 29, 2019

First Submitted That Met QC Criteria

July 31, 2019

First Posted (Actual)

August 1, 2019

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APACH2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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