Parathyroid AdenomaPhase 3APACH2NCT04040946
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 study testing MIBI scintigraphy and F18-choline PET in people with Parathyroid Adenoma and Hyperparathyroidism, run by Centre Francois Baclesse at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parathyroid Adenoma, Hyperparathyroidism, F18-choline
- What is being tested?
- MIBI scintigraphy and F18-choline PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 4 sitesFrance
- Study dates
- 19 Sep 2019to 30 Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU Brest
Brest
Centre François Baclesse
Caen, 14076
Centre Eugène Marquis
Rennes
CHU
Rennes
About this study
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
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.
- Conditions
- Parathyroid Adenoma, Hyperparathyroidism, F18-choline
- Being tested
- MIBI scintigraphy, F18-choline PET
- Medical subject headings
- Parathyroid Neoplasms, Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIBI scintigraphyDiagnostic test
Also called F18-choline PET
Performing a MIBI scintigraphy, then, in the case of negativity, a single F18-choline PET
F18-choline PETDiagnostic test
Also called MIBI scintigraphy
Realization of a F18-choline PET, then, in case of negativity, a MIBI scintigraphy
| Study group | Role | What they receive |
|---|---|---|
| TEMP-TDM with MIBI | Other | Performing a MIBI scintigraphy, then, in the case of negativity, a F18-choline PET Receives: Diagnostic Test: MIBI scintigraphy; Diagnostic Test: F18-choline PET |
| F18-choline PET | Other | Realization of F18-choline PET, then, in case of negativity, a MIBI scintigraphy Receives: Diagnostic Test: MIBI scintigraphy; Diagnostic Test: F18-choline PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare, between each diagnostic strategy, the proportion of patients for whom the first-line imaging technique guided the surgical procedure wisely
Measured: Up to 2 months
Secondary outcomes (2)
Estimate the diagnostic performance of each strategy by measuring sensitivity and specificity
Measured: Up to 2 months
Evaluate post-surgical complications by measuring tne number of infections, hematoma
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start19 Sep 2019
- Primary completion5 May 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parathyroid AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open, randomized, phase III study
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de l'Avenir
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040946
- Sponsor's protocol ID
- APACH2
- Acronym
- APACH2
- Status last verified
- Jul 2023
- First submitted
- 29 Jul 2019
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38900416Quak 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04040946
- Acronym / sponsor ID
- APACH2 / APACH2
- Conditions
- Parathyroid Adenoma, Hyperparathyroidism, F18-choline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- Fondation de l'Avenir
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open, randomized, phase III study
| Arm | Type | Receives |
|---|---|---|
| TEMP-TDM with MIBI | Other | Diagnostic Test: MIBI scintigraphy, Diagnostic Test: F18-choline PETPerforming a MIBI scintigraphy, then, in the case of negativity, a F18-choline PET |
| F18-choline PET | Other | Diagnostic Test: MIBI scintigraphy, Diagnostic Test: F18-choline PETRealization of F18-choline PET, then, in case of negativity, a MIBI scintigraphy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIBI scintigraphyAlso: F18-choline PETPerforming a MIBI scintigraphy, then, in the case of negativity, a single F18-choline PET | Diagnostic test | F18-choline PET, TEMP-TDM with MIBI |
| F18-choline PETAlso: MIBI scintigraphyRealization of a F18-choline PET, then, in case of negativity, a MIBI scintigraphy | Diagnostic test | F18-choline PET, TEMP-TDM with MIBI |
Primary outcome
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
2 secondary outcomes
Estimate the diagnostic performance of each strategy by measuring sensitivity and specificity
Time frame: Up to 2 months
Evaluate post-surgical complications by measuring tne number of infections, hematoma
Time frame: Up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Derived from this study: PubMed 38900416Quak 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.
- Derived from this study: PubMed 33413316Quak 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.
Related trials for Parathyroid Adenoma
RecruitingEarly Phase 1
Flurpiridaz F-18 PET/CT Imaging for Detecting Parathyroid Adenomas
Hyperparathyroidism
RecruitingPhase 2/3
Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
Primary Hyperparathyroidism, Parathyroid Cancer
Enrolling by invitationObservational study
Parathyroid Adenoma Detection With Rubidium-82 Imaging
Parathyroid Adenomas, Hyperparathyroidism, Primary
Active, not recruitingPhase 2
Agnostic Therapy in Rare Solid Tumors
Urachal Cancer, Parathyroid Carcinoma
RecruitingPhase 2/3
99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT
Parathyroid Adenoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MIBI scintigraphy and F18-choline PET in people with Parathyroid Adenoma and Hyperparathyroidism, run by Centre Francois Baclesse at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04040946, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.