HyperparathyroidismPhase 2APACH1NCT02432599
Interest of the F18-choline as a Second Line of the Tracer for Detection of Parathyroid Adenomas
A Phase 2 study testing F18-choline PET examination in people with Hyperparathyroidism, run by Centre Francois Baclesse at 2 sites in France.
Trial summary
The rationale for the proposed pilot study is to investigate the ability of PET-CT with F18-choline to detect and locate the parathyroid adenoma in patients with primary hyperparathyroidism and negative or non-contributory MIBI (Tc-99m sestamibi) and cervical ultrasound, in order to avoid unnecessary bilateral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperparathyroidism
- What is being tested?
- F18-choline PET examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2015to Feb 2017
- Phase
- Phase 2
- 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 aged 18 years or more;
- Patient with a primary hyperparathyroidism and witj a negative or non-contriburatory MIBI parathyroid scintigraphy and neck ultrasonography, for which surgical resection is planned;
- Confirmation of the diagnosis of primary hyperparathyroidism on laboratory tests
- Affiliate to a social security system;
- Patient written informed consent.
Who cannot join
- Patient deprived of liberty, under guardianship;
- Any medical or psychological condition witch could compromise the capacity of the patient to participate in the study;
- Pregnant or breastfeeding
Trial locations and contacts
2 sites in 1 country.
About this study
The rationale for the proposed pilot study is to investigate the ability of PET-CT with F18-choline to detect and locate the parathyroid adenoma in patients with primary hyperparathyroidism and negative or non-contributory MIBI (Tc-99m sestamibi) and cervical ultrasound, in order to avoid unnecessary bilateral cervical exploration.
- Conditions
- Hyperparathyroidism
- Being tested
- F18-choline PET examination
- Keywords
- F18-choline
- Medical subject headings
- Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F18-choline PET examinationRadiation
F18-choline PET examination will be performed before surgery
| Study group | Role | What they receive |
|---|---|---|
| F18-choline PET | Experimental | F18-choline PET examination will be performed before surgery Receives: Radiation: F18-choline PET examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity (ability to identify and visualize the parathyroid adenoma)
Sensitivity of PET-CT with F18-choline (FCH) to identify and visualize the parathyroid adenoma in patients with primary hyperparathyroidism and negative or non-contributory parathyroid scintigraphy MIBI and cervical ultrasound
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 posted4 May 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperparathyroidismStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432599
- Sponsor's protocol ID
- APACH1
- Acronym
- APACH1
- Status last verified
- Aug 2016
- First submitted
- 29 Apr 2015
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Quak E, Blanchard D, Houdu B, Le Roux Y, Ciappuccini R, Lireux B, de Raucourt D, Grellard JM, Licaj I, Bardet S, Reznik Y, Clarisse B, Aide N. F18-choline PET/CT guided surgery in primary hyperparathyroidism when ultrasound and MIBI SPECT/CT are negative or inconclusive: the APACH1 study. Eur J Nucl Med Mol Imaging. 2018 Apr;45(4):658-666. doi: 10.1007/s00259-017-3911-1. Epub 2017 Dec 22.
PubMed 29270788
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the F18-choline as a Second Line of the Tracer for Detection of Parathyroid Adenomas
- ClinicalTrials.gov ID
- NCT02432599
- Acronym / sponsor ID
- APACH1 / APACH1
- Conditions
- Hyperparathyroidism
- Keywords
- F18-choline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 4 May 2015 (estimated)
- 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 rationale for the proposed pilot study is to investigate the ability of PET-CT with F18-choline to detect and locate the parathyroid adenoma in patients with primary hyperparathyroidism and negative or non-contributory MIBI (Tc-99m sestamibi) and cervical ultrasound, in order to avoid unnecessary bilateral cervical exploration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F18-choline PET | Experimental | Radiation: F18-choline PET examinationF18-choline PET examination will be performed before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged 18 years or more;
- Patient with a primary hyperparathyroidism and witj a negative or non-contriburatory MIBI parathyroid scintigraphy and neck ultrasonography, for which surgical resection is planned;
- Confirmation of the diagnosis of primary hyperparathyroidism on laboratory tests
- Affiliate to a social security system;
- Patient written informed consent.
Key exclusion criteria (3 listed)
- Patient deprived of liberty, under guardianship;
- Any medical or psychological condition witch could compromise the capacity of the patient to participate in the study;
- Pregnant or breastfeeding
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 |
|---|---|---|
| F18-choline PET examinationF18-choline PET examination will be performed before surgery | Radiation | F18-choline PET |
Primary outcome
Sensitivity (ability to identify and visualize the parathyroid adenoma)
Time frame: Up to 2 months
Sensitivity of PET-CT with F18-choline (FCH) to identify and visualize the parathyroid adenoma in patients with primary hyperparathyroidism and negative or non-contributory parathyroid scintigraphy MIBI and cervical ultrasound
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 4 Jan 2018.
- Derived from this study: PubMed 29270788Quak E, Blanchard D, Houdu B, Le Roux Y, Ciappuccini R, Lireux B, de Raucourt D, Grellard JM, Licaj I, Bardet S, Reznik Y, Clarisse B, Aide N. F18-choline PET/CT guided surgery in primary hyperparathyroidism when ultrasound and MIBI SPECT/CT are negative or inconclusive: the APACH1 study. Eur J Nucl Med Mol Imaging. 2018 Apr;45(4):658-666. doi: 10.1007/s00259-017-3911-1. Epub 2017 Dec 22.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing F18-choline PET examination in people with Hyperparathyroidism, run by Centre Francois Baclesse at 2 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 5 inclusion and 3 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 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Sensitivity (ability to identify and visualize the parathyroid adenoma) (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 NCT02432599, which also lists 1 linked publication.
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 4 Jan 2018.