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)
Primary Purpose
Parathyroid Adenoma, Hyperparathyroidism, F18-choline
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
MIBI scintigraphy
F18-choline PET
Sponsored by
About this trial
This is an interventional diagnostic trial for Parathyroid Adenoma
Eligibility Criteria
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)
Sites / Locations
- CHU Brest
- Centre François Baclesse
- Centre Eugène Marquis
- CHU
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
TEMP-TDM with MIBI
F18-choline PET
Arm Description
Performing a MIBI scintigraphy, then, in the case of negativity, a F18-choline PET
Realization of F18-choline PET, then, in case of negativity, a MIBI scintigraphy
Outcomes
Primary Outcome Measures
Compare, between each diagnostic strategy, the proportion of patients for whom the first-line imaging technique guided the surgical procedure wisely
Secondary Outcome Measures
Estimate the diagnostic performance of each strategy by measuring sensitivity and specificity
Evaluate post-surgical complications by measuring tne number of infections, hematoma
Full Information
NCT ID
NCT04040946
First Posted
July 29, 2019
Last Updated
July 31, 2023
Sponsor
Centre Francois Baclesse
Collaborators
Fondation de l'Avenir
1. Study Identification
Unique Protocol Identification Number
NCT04040946
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 19, 2019 (Actual)
Primary Completion Date
May 5, 2022 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
Collaborators
Fondation de l'Avenir
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parathyroid Adenoma, Hyperparathyroidism, F18-choline
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Open, randomized, phase III study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TEMP-TDM with MIBI
Arm Type
Other
Arm Description
Performing a MIBI scintigraphy, then, in the case of negativity, a F18-choline PET
Arm Title
F18-choline PET
Arm Type
Other
Arm Description
Realization of F18-choline PET, then, in case of negativity, a MIBI scintigraphy
Intervention Type
Diagnostic Test
Intervention Name(s)
MIBI scintigraphy
Other Intervention Name(s)
F18-choline PET
Intervention Description
Performing a MIBI scintigraphy, then, in the case of negativity, a single F18-choline PET
Intervention Type
Diagnostic Test
Intervention Name(s)
F18-choline PET
Other Intervention Name(s)
MIBI scintigraphy
Intervention Description
Realization of a F18-choline PET, then, in case of negativity, a MIBI scintigraphy
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Estimate the diagnostic performance of each strategy by measuring sensitivity and specificity
Time Frame
Up to 2 months
Title
Evaluate post-surgical complications by measuring tne number of infections, hematoma
Time Frame
Up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
CHU Brest
City
Brest
Country
France
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
Country
France
Facility Name
CHU
City
Rennes
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
33413316
Citation
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.
Results Reference
derived
Learn more about this trial
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
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