Primary Aldosteronism With Bilateral Adrenal LesionsNCT06247566
68Ga-Pentixafor PET/CT for Guiding Surgical Treatment of Primary Aldosteronism With Bilateral Adrenal Lesions
An observational study of Primary Aldosteronism With Bilateral Adrenal Lesions, run by Central South University at 1 site in China.
Trial summary
Screening potential candidates who may benefit from surgery remains challenging for patients diagnosed with primary aldosteronism (PA) accompanied by bilateral adrenal lesions. Although adrenal venous sampling is currently the gold standard, it is a technically cumbersome, challenging, and difficult-to-interpret… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Aldosteronism With Bilateral Adrenal Lesions
- How many people
- 83 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 1 Jul 2023
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with bilateral adrenal lesions who were diagnosed as PA from January 1, 2020, to July 1, 2023
Who may be able to join
- patients with bilateral adrenal lesions who were diagnosed as PA
Who cannot join
- patients diagnosed with other types of secondary hypertension
- patients had comorbidities
- Patients with incomplete follow-up data
- Patients who successfully underwent AVS
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Urology, Xiangya Hospital, Central South University
Changsha, Hu'nan, 410008
About this study
Official title: CXCR4-targeted 68Ga-Pentixafor PET/CT for Guiding Surgical Treatment of Primary Aldosteronism With Bilateral Adrenal Lesions: Preliminary Results From a Single-center Retrospective Study
Screening potential candidates who may benefit from surgery remains challenging for patients diagnosed with primary aldosteronism (PA) accompanied by bilateral adrenal lesions. Although adrenal venous sampling is currently the gold standard, it is a technically cumbersome, challenging, and difficult-to-interpret invasive procedure that requires a cutting-edge facility and radiologists with a high level of expertise, which restricts its widespread use. The present study aimed to assess the comprehensive effect of 68Ga-pentixafor positron emission tomography/computer tomography (PET/CT) on guiding surgical treatments for PA patients with bilateral adrenal lesions.
Read the detailed description
Primary aldosteronism (PA) is characterized by the overproduction of renin-independent aldosterone, which results in increased blood volume, potassium excretion, and sodium storage in the body, as well as the inhibition of renin-angiotensin system activity. Clinically, the condition frequently presents as hypertension and hypokalemia. Patients with PA are at a much higher risk of experiencing cardiovascular and cerebrovascular complications than those with primary hypertension matched by blood pressure. PA is classified into two subtypes: unilateral aldosterone hypersecretion (most often aldosterone-producing adenoma (APA)) and contralateral aldosterone non-secretion or bilateral aldosterone hypersecretion (most often idiopathic hyperaldosteronism (IHA)). Differentiating PA subtypes is crucial, as patients with unilateral adrenal hypersecretion of aldosterone may be cured by the surgical removal of the adrenal lesion. Moreover, mineralocorticoid-receptor antagonists (MRAs) are the choice therapy for patients with bilateral hypersecretion.
Computed tomography (CT) is a useful tool for identifying and analyzing abnormalities in the adrenal gland and is one of the main methods used to distinguish between unilateral and bilateral adrenal lesions. CT images with abnormalities on only one side of the adrenal gland in young PA patients (aged <35 years) suggest that abnormal hypersecretion of aldosterone is caused by the unilateral adrenal lesion. However, PA patients with bilateral adrenal lesions on CT do not necessarily exhibit excessive aldosterone secretion. Aldosterone hypersecretion may occur in only one side of the gland. However, because CT does not provide enough information about the secretory activity of a detected nodule, it is difficult to distinguish the side of the adrenal lesion that secretes excessive aldosterone. In recent years, adrenal vein sampling (AVS) - which determines lesions with functional aldosterone secretion - has been considered the gold standard for identifying PA subtypes with bilateral adrenal lesions. However, the feasibility of AVS remains controversial because of its substantial cost, invasiveness with potential risks, and complicated technique with a relatively high rate of failure. Therefore, in regions where AVS is infeasible, experienced physicians may recommend MRAs treatment directly, or the suspected aldosterone-producing lesions may be removed based on the severity of the disease and adrenal CT features. In the latter setting, larger lesions or the side of lesions with radiological features of classic cortical adenoma are often removed, but these lesions may be non-functional. Therefore, this empirical method has a high risk of failure in disease control. Hence, considerable efforts have been made to identify a cost-effective, convenient, and non-invasive substitution for AVS. The utilization of functional imaging techniques is promising for detecting aldosterone-secreting adrenal lesions. For instance, the performance of 11C-metomidate positron emission tomography/computer tomography (PET/CT) is comparable to that of AVS. However, the short half-life of 11C-metomidate and higher requirements for equipment limits its widespread application in clinical practice.
The C-X-C chemokine receptor 4 (CXCR4) - a G protein-coupled transmembrane receptor - is highly expressed in aldosterone-producing tissue16. Its expression is strongly correlated with the expression of aldosterone synthase CYP11B2 (cytochrome P450, family, subfamily b, polypeptide 2). The utilization of 68Ga-pentixafor, a radiolabeled CXCR4 ligand, enables the visualization of tissues exhibiting elevated CXCR4 expression on PET/CT by specifically binding to CXCR4 receptors on the cell membrane 18. Evidence has shown that the utilization of 68Ga-pentixafor PET/CT in patients with adrenal lesions reveals a notable disparity in the uptake value of the tracer between the adrenal lesion side generating excessive aldosterone and non-functional adrenal adenomas (NFA). Previous study also showed that 68Ga-pentixafor PET/CT has diagnostic significance in PA subtypes. We found that the maximum standardized uptake value (SUVmax) of IHA lesions and NFA was significantly lower than that of APA. However, studies on the value of PET/CT in patients with PA coupled with bilateral adrenal lesions are scanty. Herein, we employed 68Ga-pentixafor PET/CT imaging to evaluate PA patients with bilateral adrenal lesions who may receive surgical benefits and tracked their prognosis to examine the significance of 68Ga-pentixafor PET/CT in guiding the treatment strategy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-Pentixafor PET/CT | Patients with Primary Aldosteronism (PA) accompanied by bilateral adrenal lesions undergoing 68Ga-Pentixafor PET/CT to discriminate PA forms with unilateral from bilateral excess aldosterone production, so as to determine whether to choose surgical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the the maximum standardized uptake value of adrenal lesions
Measured: January 1st 2021 - July 1st 2023
Secondary outcomes (2)
number of patients with lateralization indicated by PET/ CT
Measured: January 1st 2021 - July 1st 2023
number of the patients undergoing adrenalectomy
Measured: January 1st 2021 - July 1st 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Nov 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
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 Primary Aldosteronism With Bilateral Adrenal LesionsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhiwei shu, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247566
- Sponsor's protocol ID
- zshu
- Status last verified
- Feb 2024
- First submitted
- 31 Jan 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shu Z, He Y, Long T, Guo M, Xia Z, Fu X, Li B, Zhang B, Yang Y, Chen J, Jiang T, Chen X, Cheng K, Liu L, Gan Y. Is CXCR4-targeted 68Ga-pentixafor PET/CT a reliable AVS-free modality for surgical decision-making and prognostic prediction in primary aldosteronism with bilateral adrenal lesions? EJNMMI Res. 2025 Aug 28;15(1):111. doi: 10.1186/s13550-025-01309-4.
PubMed 40875090
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CXCR4-targeted 68Ga-Pentixafor PET/CT for Guiding Surgical Treatment of Primary Aldosteronism With Bilateral Adrenal Lesions: Preliminary Results From a Single-center Retrospective Study
- ClinicalTrials.gov ID
- NCT06247566
- Acronym / sponsor ID
- zshu
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 8 Feb 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.
Screening potential candidates who may benefit from surgery remains challenging for patients diagnosed with primary aldosteronism (PA) accompanied by bilateral adrenal lesions. Although adrenal venous sampling is currently the gold standard, it is a technically cumbersome, challenging, and difficult-to-interpret invasive procedure that requires a cutting-edge facility and radiologists with a high level of expertise, which restricts its widespread use. The present study aimed to assess the comprehensive effect of 68Ga-pentixafor positron emission tomography/computer tomography (PET/CT) on guiding surgical treatments for PA patients with bilateral adrenal lesions.
Detailed description
Primary aldosteronism (PA) is characterized by the overproduction of renin-independent aldosterone, which results in increased blood volume, potassium excretion, and sodium storage in the body, as well as the inhibition of renin-angiotensin system activity. Clinically, the condition frequently presents as hypertension and hypokalemia. Patients with PA are at a much higher risk of experiencing cardiovascular and cerebrovascular complications than those with primary hypertension matched by blood pressure. PA is classified into two subtypes: unilateral aldosterone hypersecretion (most often aldosterone-producing adenoma (APA)) and contralateral aldosterone non-secretion or bilateral aldosterone hypersecretion (most often idiopathic hyperaldosteronism (IHA)). Differentiating PA subtypes is crucial, as patients with unilateral adrenal hypersecretion of aldosterone may be cured by the surgical removal of the adrenal lesion. Moreover, mineralocorticoid-receptor antagonists (MRAs) are the choice therapy for patients with bilateral hypersecretion.
Computed tomography (CT) is a useful tool for identifying and analyzing abnormalities in the adrenal gland and is one of the main methods used to distinguish between unilateral and bilateral adrenal lesions. CT images with abnormalities on only one side of the adrenal gland in young PA patients (aged <35 years) suggest that abnormal hypersecretion of aldosterone is caused by the unilateral adrenal lesion. However, PA patients with bilateral adrenal lesions on CT do not necessarily exhibit excessive aldosterone secretion. Aldosterone hypersecretion may occur in only one side of the gland. However, because CT does not provide enough information about the secretory activity of a detected nodule, it is difficult to distinguish the side of the adrenal lesion that secretes excessive aldosterone. In recent years, adrenal vein sampling (AVS) - which determines lesions with functional aldosterone secretion - has been considered the gold standard for identifying PA subtypes with bilateral adrenal lesions. However, the feasibility of AVS remains controversial because of its substantial cost, invasiveness with potential risks, and complicated technique with a relatively high rate of failure. Therefore, in regions where AVS is infeasible, experienced physicians may recommend MRAs treatment directly, or the suspected aldosterone-producing lesions may be removed based on the severity of the disease and adrenal CT features. In the latter setting, larger lesions or the side of lesions with radiological features of classic cortical adenoma are often removed, but these lesions may be non-functional. Therefore, this empirical method has a high risk of failure in disease control. Hence, considerable efforts have been made to identify a cost-effective, convenient, and non-invasive substitution for AVS. The utilization of functional imaging techniques is promising for detecting aldosterone-secreting adrenal lesions. For instance, the performance of 11C-metomidate positron emission tomography/computer tomography (PET/CT) is comparable to that of AVS. However, the short half-life of 11C-metomidate and higher requirements for equipment limits its widespread application in clinical practice.
The C-X-C chemokine receptor 4 (CXCR4) - a G protein-coupled transmembrane receptor - is highly expressed in aldosterone-producing tissue16. Its expression is strongly correlated with the expression of aldosterone synthase CYP11B2 (cytochrome P450, family, subfamily b, polypeptide 2). The utilization of 68Ga-pentixafor, a radiolabeled CXCR4 ligand, enables the visualization of tissues exhibiting elevated CXCR4 expression on PET/CT by specifically binding to CXCR4 receptors on the cell membrane 18. Evidence has shown that the utilization of 68Ga-pentixafor PET/CT in patients with adrenal lesions reveals a notable disparity in the uptake value of the tracer between the adrenal lesion side generating excessive aldosterone and non-functional adrenal adenomas (NFA). Previous study also showed that 68Ga-pentixafor PET/CT has diagnostic significance in PA subtypes. We found that the maximum standardized uptake value (SUVmax) of IHA lesions and NFA was significantly lower than that of APA. However, studies on the value of PET/CT in patients with PA coupled with bilateral adrenal lesions are scanty. Herein, we employed 68Ga-pentixafor PET/CT imaging to evaluate PA patients with bilateral adrenal lesions who may receive surgical benefits and tracked their prognosis to examine the significance of 68Ga-pentixafor PET/CT in guiding the treatment strategy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-Pentixafor PET/CT | – | –Patients with Primary Aldosteronism (PA) accompanied by bilateral adrenal lesions undergoing 68Ga-Pentixafor PET/CT to discriminate PA forms with unilateral from bilateral excess aldosterone production, so as to determine whether to choose surgical treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with bilateral adrenal lesions who were diagnosed as PA from January 1, 2020, to July 1, 2023
Key inclusion criteria (1 listed)
- patients with bilateral adrenal lesions who were diagnosed as PA
Key exclusion criteria (4 listed)
- patients diagnosed with other types of secondary hypertension
- patients had comorbidities
- Patients with incomplete follow-up data
- Patients who successfully underwent AVS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the the maximum standardized uptake value of adrenal lesions
Time frame: January 1st 2021 - July 1st 2023
2 secondary outcomes
number of patients with lateralization indicated by PET/ CT
Time frame: January 1st 2021 - July 1st 2023
number of the patients undergoing adrenalectomy
Time frame: January 1st 2021 - July 1st 2023
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 9 Feb 2024.
- Derived from this study: PubMed 40875090Shu Z, He Y, Long T, Guo M, Xia Z, Fu X, Li B, Zhang B, Yang Y, Chen J, Jiang T, Chen X, Cheng K, Liu L, Gan Y. Is CXCR4-targeted 68Ga-pentixafor PET/CT a reliable AVS-free modality for surgical decision-making and prognostic prediction in primary aldosteronism with bilateral adrenal lesions? EJNMMI Res. 2025 Aug 28;15(1):111. doi: 10.1186/s13550-025-01309-4.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism With Bilateral Adrenal Lesions, run by Central South University 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 1 inclusion and 4 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 9 Feb 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?
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?
the the maximum standardized uptake value of adrenal lesions (time frame: January 1st 2021 - July 1st 2023). 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 NCT06247566, 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 9 Feb 2024.