Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)NCT06581744
Non Invasive Imaging Methods for Detecting PA：a Clinical PET Study of 18F-Pentixather
A study testing [18F]AlF-NOTA-Pentixather in people with Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral), run by Fangfang Sun at 1 site in China.
Trial summary
Primary aldosteronism (PA) is the most common endocrine cause of hypertension. 68Ga-pentixafor PET/CT possesses a relatively high sensitivity and specificity for Aldosterone producing adenoma (APA) detection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
- What is being tested?
- [18F]AlF-NOTA-Pentixather
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2024to 30 Jun 2026
- Phase
- Interventional
- 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
- Patients diagnosed with primary aldosteronism and willing to undergo surgery
- Clinically highly suspected of primary aldosteronism, but the diagnostic test cannot clearly identify the patients
- Postoperative recurrence in patients with primary aldosteronism
Who cannot join
- Pregnant and lactating women.
- Patients with poor autonomous behavior ability, severe claustrophobia, and critically ill patients requiring life support who are unable to cooperate in completing the examination.
- There are other situations where patients are not suitable for this examination
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116022
Lei Xu, PHD, +8641183010706, dyyyirb@163.com
About this study
Official title: Non Invasive Imaging Methods for Detecting Primary Aldosteronism： a Clinical Positron EmissionTomography (PET) Study of 18F-Pentixather
Primary aldosteronism (PA) is the most common endocrine cause of hypertension. 68Ga-pentixafor PET/CT possesses a relatively high sensitivity and specificity for Aldosterone producing adenoma (APA) detection. However, 68Ga is usually eluted from a 68Ge-68Ga generator, only a small amount of isotopes can be achieved once time. [18F]AlF-chelation is a promising strategy that would solve these issues. 18F labeled Pentixafor-Based Imaging Agent([18F]AlF-NOTA-Pentixather) has been reported by Andreas Poschenrieder. [18F]AlF-NOTA-Pentixather displayed high and CXCR4-specific in vivo uptake in Daudi xenografts (13.9%±0.8% injected dose per gram [ID/g] at 1 hour post injection[p.i.]). But to date 18F-Pentixather has not been studied in humans. In this program the investigators will estimate the radiation dosimetry of [18F]AlF-NOTA-Pentixather, evaluate the sensitivity and specificity of the [18F]AlF-NOTA-Pentixather as a probe for APA.
- Being tested
- [18F]AlF-NOTA-Pentixather
- Keywords
- Primary aldosteronism, Radiation Dosimetry, 18F-Pentixather
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]AlF-NOTA-PentixatherOther
inject 185~370MBq [18F]AlF-NOTA-Pentixather
| Study group | Role | What they receive |
|---|---|---|
| hyperaldosteronism | Experimental | Intravenous inject 18F-Pentixather，perform PET/CT imaging at the designated time Receives: Other: [18F]AlF-NOTA-Pentixather |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of radiation dosimetry and biodistribution of 18F-Pentixather determined with PET/CT in Patients with PA
Images were acquired using a Biograph Truepoint 64 PET/CT scanner (Siemens, Erlangen, Germany).The dosimetry analysis was performed using 3d-slicer（version 5.6.1, with slicerOpenDose3D module (https://gitlab.com/opendose/opendose3d). OpenDose: open access resources for nuclear medicine dosimetry (www.opendose.org).
Measured: 6 month
Analyze the specificity and sensitivity of 18F-pentixather PET/CT for the diagnosis of APA
Compare the 18F-Pentixather SUVmax with the CXCR4，CYP11B2 immunohistochemical score. Calculate the sensitivity and specificity of 18F-pentixafor PET/CT results for an indication of APA, IAH, or NFA lesions.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start12 Jun 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2026 (estimated)
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 Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)Studies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fangfang Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fangfang Sun, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581744
- Sponsor's protocol ID
- HYX001
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zheng Y, Long T, Peng N, Zhen M, Ye Q, Zhang Z, He Y, Chen Z, Gan Y, Luo M, Li C, Liu Z, Guo M, Wang M, Luo X, Hu S, Liu L, Jiang T. The Value of Targeting CXCR4 With 68Ga-Pentixafor PET/CT for Subtyping Primary Aldosteronism. J Clin Endocrinol Metab. 2023 Dec 21;109(1):171-182. doi: 10.1210/clinem/dgad421.
PubMed 37477496Gao Y, Ding J, Cui Y, Li T, Sun H, Zhao D, Zhang Y, Huo L, Tong A. Functional nodules in primary aldosteronism: identification of CXCR4 expression with 68Ga-pentixafor PET/CT. Eur Radiol. 2023 Feb;33(2):996-1003. doi: 10.1007/s00330-022-09058-x. Epub 2022 Sep 7.
PubMed 36070092
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Imaging Methods for Detecting Primary Aldosteronism： a Clinical Positron EmissionTomography (PET) Study of 18F-Pentixather
- ClinicalTrials.gov ID
- NCT06581744
- Acronym / sponsor ID
- HYX001
- Keywords
- Primary aldosteronism, Radiation Dosimetry, 18F-Pentixather
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fangfang SunUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 3 Sep 2024 (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.
Primary aldosteronism (PA) is the most common endocrine cause of hypertension. 68Ga-pentixafor PET/CT possesses a relatively high sensitivity and specificity for Aldosterone producing adenoma (APA) detection. However, 68Ga is usually eluted from a 68Ge-68Ga generator, only a small amount of isotopes can be achieved once time. [18F]AlF-chelation is a promising strategy that would solve these issues. 18F labeled Pentixafor-Based Imaging Agent([18F]AlF-NOTA-Pentixather) has been reported by Andreas Poschenrieder. [18F]AlF-NOTA-Pentixather displayed high and CXCR4-specific in vivo uptake in Daudi xenografts (13.9%±0.8% injected dose per gram [ID/g] at 1 hour post injection[p.i.]). But to date 18F-Pentixather has not been studied in humans. In this program the investigators will estimate the radiation dosimetry of [18F]AlF-NOTA-Pentixather, evaluate the sensitivity and specificity of the [18F]AlF-NOTA-Pentixather as a probe for APA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hyperaldosteronism | Experimental | Other: [18F]AlF-NOTA-PentixatherIntravenous inject 18F-Pentixather，perform PET/CT imaging at the designated time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with primary aldosteronism and willing to undergo surgery
- Clinically highly suspected of primary aldosteronism, but the diagnostic test cannot clearly identify the patients
- Postoperative recurrence in patients with primary aldosteronism
Key exclusion criteria (3 listed)
- Pregnant and lactating women.
- Patients with poor autonomous behavior ability, severe claustrophobia, and critically ill patients requiring life support who are unable to cooperate in completing the examination.
- There are other situations where patients are not suitable for this examination
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 |
|---|---|---|
| [18F]AlF-NOTA-Pentixatherinject 185~370MBq [18F]AlF-NOTA-Pentixather | Other | hyperaldosteronism |
Primary outcome
Measurement of radiation dosimetry and biodistribution of 18F-Pentixather determined with PET/CT in Patients with PA
Time frame: 6 month
Images were acquired using a Biograph Truepoint 64 PET/CT scanner (Siemens, Erlangen, Germany).The dosimetry analysis was performed using 3d-slicer（version 5.6.1, with slicerOpenDose3D module (https://gitlab.com/opendose/opendose3d). OpenDose: open access resources for nuclear medicine dosimetry (www.opendose.org).
Analyze the specificity and sensitivity of 18F-pentixather PET/CT for the diagnosis of APA
Time frame: 3 years
Compare the 18F-Pentixather SUVmax with the CXCR4，CYP11B2 immunohistochemical score. Calculate the sensitivity and specificity of 18F-pentixafor PET/CT results for an indication of APA, IAH, or NFA lesions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Results publication: PubMed 37477496Zheng Y, Long T, Peng N, Zhen M, Ye Q, Zhang Z, He Y, Chen Z, Gan Y, Luo M, Li C, Liu Z, Guo M, Wang M, Luo X, Hu S, Liu L, Jiang T. The Value of Targeting CXCR4 With 68Ga-Pentixafor PET/CT for Subtyping Primary Aldosteronism. J Clin Endocrinol Metab. 2023 Dec 21;109(1):171-182. doi: 10.1210/clinem/dgad421.
- Results publication: PubMed 36070092Gao Y, Ding J, Cui Y, Li T, Sun H, Zhao D, Zhang Y, Huo L, Tong A. Functional nodules in primary aldosteronism: identification of CXCR4 expression with 68Ga-pentixafor PET/CT. Eur Radiol. 2023 Feb;33(2):996-1003. doi: 10.1007/s00330-022-09058-x. Epub 2022 Sep 7.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]AlF-NOTA-Pentixather in people with Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral), run by Fangfang Sun at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fangfang Sun, MD (18098876916, sf.f@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of radiation dosimetry and biodistribution of 18F-Pentixather determined with PET/CT in Patients with PA (time frame: 6 month). The study lists 2 primary outcomes in all. 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 NCT06581744, 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 3 Sep 2024.