Primary Aldosteronism Concurrent With Autonomous Cortisol SecretionNCT07605156
Diagnostic Value of 68Ga-Pentixafor PET/CT in Adrenal Tumors With Aldosterone and Cortisol Cosecretion
An observational study of Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion, run by Peking University First Hospital at 1 site in China.
Trial summary
The goal of this observational study is to evaluate the diagnostic accuracy of 68 68 Ga-Pentixafor-CXCR4 PET/CT in identifying the dominant side of hormone excess in adult patients (aged 18-80 years) with primary aldosteronism and concomitant mild autonomous cortisol secretion (PA+MACS) who are candidates for… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 30 Sep 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Adult, Older adult
Study population: The study population consists of adult patients aged 18-80 years with a confirmed diagnosis of primary aldosteronism and concomitant mild autonomous cortisol secretion (PA+MACS), who are scheduled to undergo [⁶⁸Ga]Pentixafor-CXCR4 PET/CT imaging and meet clinical indications for unilateral adrenalectomy or adrenal ablation. Participants are recruited consecutively from outpatient and inpatient settings at Peking University First Hospital, including both prospectively enrolled patients and retrospectively identified patients with previously confirmed PA+MACS and available clinical data. All participants must provide written informed consent and be willing to complete at least 12 months of postoperative follow-up.
Who may be able to join
- Age 18-80 years.
- Confirmed diagnosis of PA+MACS according to guideline-directed algorithms: elevated aldosterone-to-renin ratio (ARR) and at least one positive confirmatory test for primary aldosteronism, together with serum cortisol >1.8 µg/dL (>50 nmol/L) after a 1 mg overnight dexamethasone suppression test (1 mg-ONDST).
- Scheduled to undergo [⁶⁸Ga]Pentixafor-CXCR4 PET/CT imaging.
- Meeting surgical indications, scheduled for adrenalectomy or adrenal ablation, having provided written informed consent, and agreeing to a follow-up of at least 12 months.
Who cannot join
- Previous adrenal surgery or confirmed adrenal malignancy.
- Pregnancy or lactation.
- Severe renal impairment (eGFR <30 mL·min-¹·1.73 m-²) or contraindication to contrast agents/radiopharmaceuticals.
- Inability to discontinue medications that interfere with diagnostic testing according to protocol, or presence of severe infection/unstable comorbidities that preclude relevant examinations.
- Definite overt Cushing's syndrome (CS).
- Critical missing data, inability to complete the required examinations, or anticipated inability to attend follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital, Beijing
Beijing
Peking University First Hospital Peking University First Hospital, 01083572418, 2300736651@qq.com
About this study
The goal of this observational study is to evaluate the diagnostic accuracy of 68 68
Ga-Pentixafor-CXCR4 PET/CT in identifying the dominant side of hormone excess in adult patients (aged 18-80 years) with primary aldosteronism and concomitant mild autonomous cortisol secretion (PA+MACS) who are candidates for unilateral adrenalectomy or ablation. The main questions it aims to answer are:
Read more
What is the overall diagnostic performance of 68 68 Ga-Pentixafor-CXCR4 PET/CT for lateralizing the dominant source of aldosterone and cortisol co-secretion, as measured by the area under the receiver operating characteristic curve (AUC)?
How do the PET/CT-based lateralization results compare with adrenal venous sampling (AVS) and metanephrine-corrected AVS, and are there clinical or biochemical factors that predict discordance between these methods?
Researchers will compare the dominant side determined by PET/CT with the reference standard derived from postoperative PASO outcomes and cortisol-related hormonal outcomes (supplemented by histopathology) to assess sensitivity, specificity, accuracy, and agreement. They will further compare PET/CT results to conventional AVS and metanephrine-corrected AVS to determine concordance and identify potential predictors of discordant cases.
Participants will:
Provide written informed consent and undergo baseline clinical, biochemical, and imaging assessments as part of routine PA+MACS work-up.
Undergo a single 68 68 Ga-Pentixafor-CXCR4 PET/CT scan, along with AVS and metanephrine-corrected AVS, typically within a 4-week window.
Be discussed by a multidisciplinary team that integrates all diagnostic information to formulate an individualized surgical plan.
If surgery proceeds, be followed at 1, 3, 6, and 12 months postoperatively to assess blood pressure, antihypertensive medication use, serum potassium, aldosterone/renin/cortisol levels, and 1-mg overnight dexamethasone suppression test results.
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the receiver operating characteristic curve (AUC) for 68Ga-Pentixafor-CXCR4 PET/CT in determining the dominant side of adrenal hormone excess in patients with primary aldosteronism and concomitant mild autonomous cortisol secretion (PA+MACS）
Measured: From enrollment to 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Dec 2025
- Primary completion31 May 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Aldosteronism Concurrent With Autonomous Cortisol SecretionStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 130 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605156
- Sponsor's protocol ID
- SFMSSXPETCT
- Status last verified
- Mar 2026
- First submitted
- 17 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of 68Ga-Pentixafor PET/CT in Adrenal Tumors With Aldosterone and Cortisol Cosecretion
- ClinicalTrials.gov ID
- NCT07605156
- Acronym / sponsor ID
- SFMSSXPETCT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 22 May 2026 (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 goal of this observational study is to evaluate the diagnostic accuracy of 68 68
Ga-Pentixafor-CXCR4 PET/CT in identifying the dominant side of hormone excess in adult patients (aged 18-80 years) with primary aldosteronism and concomitant mild autonomous cortisol secretion (PA+MACS) who are candidates for unilateral adrenalectomy or ablation. The main questions it aims to answer are:
What is the overall diagnostic performance of 68 68 Ga-Pentixafor-CXCR4 PET/CT for lateralizing the dominant source of aldosterone and cortisol co-secretion, as measured by the area under the receiver operating characteristic curve (AUC)?
How do the PET/CT-based lateralization results compare with adrenal venous sampling (AVS) and metanephrine-corrected AVS, and are there clinical or biochemical factors that predict discordance between these methods?
Researchers will compare the dominant side determined by PET/CT with the reference standard derived from postoperative PASO outcomes and cortisol-related hormonal outcomes (supplemented by histopathology) to assess sensitivity, specificity, accuracy, and agreement. They will further compare PET/CT results to conventional AVS and metanephrine-corrected AVS to determine concordance and identify potential predictors of discordant cases.
Participants will:
Provide written informed consent and undergo baseline clinical, biochemical, and imaging assessments as part of routine PA+MACS work-up.
Undergo a single 68 68 Ga-Pentixafor-CXCR4 PET/CT scan, along with AVS and metanephrine-corrected AVS, typically within a 4-week window.
Be discussed by a multidisciplinary team that integrates all diagnostic information to formulate an individualized surgical plan.
If surgery proceeds, be followed at 1, 3, 6, and 12 months postoperatively to assess blood pressure, antihypertensive medication use, serum potassium, aldosterone/renin/cortisol levels, and 1-mg overnight dexamethasone suppression test results.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18-80 years with a confirmed diagnosis of primary aldosteronism and concomitant mild autonomous cortisol secretion (PA+MACS), who are scheduled to undergo [⁶⁸Ga]Pentixafor-CXCR4 PET/CT imaging and meet clinical indications for unilateral adrenalectomy or adrenal ablation. Participants are recruited consecutively from outpatient and inpatient settings at Peking University First Hospital, including both prospectively enrolled patients and retrospectively identified patients with previously confirmed PA+MACS and available clinical data. All participants must provide written informed consent and be willing to complete at least 12 months of postoperative follow-up.
Key inclusion criteria (4 listed)
- Age 18-80 years.
- Confirmed diagnosis of PA+MACS according to guideline-directed algorithms: elevated aldosterone-to-renin ratio (ARR) and at least one positive confirmatory test for primary aldosteronism, together with serum cortisol >1.8 µg/dL (>50 nmol/L) after a 1 mg overnight dexamethasone suppression test (1 mg-ONDST).
- Scheduled to undergo [⁶⁸Ga]Pentixafor-CXCR4 PET/CT imaging.
- Meeting surgical indications, scheduled for adrenalectomy or adrenal ablation, having provided written informed consent, and agreeing to a follow-up of at least 12 months.
Key exclusion criteria (6 listed)
- Previous adrenal surgery or confirmed adrenal malignancy.
- Pregnancy or lactation.
- Severe renal impairment (eGFR <30 mL·min-¹·1.73 m-²) or contraindication to contrast agents/radiopharmaceuticals.
- Inability to discontinue medications that interfere with diagnostic testing according to protocol, or presence of severe infection/unstable comorbidities that preclude relevant examinations.
- Definite overt Cushing's syndrome (CS).
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
area under the receiver operating characteristic curve (AUC) for 68Ga-Pentixafor-CXCR4 PET/CT in determining the dominant side of adrenal hormone excess in patients with primary aldosteronism and concomitant mild autonomous cortisol secretion (PA+MACS）
Time frame: From enrollment to 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
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 Concurrent With Autonomous Cortisol Secretion, run by Peking University First Hospital 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 22 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Baojiang Wu Wu (01013231338962, 2300736651@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
area under the receiver operating characteristic curve (AUC) for 68Ga-Pentixafor-CXCR4 PET/CT in determining the dominant side of adrenal hormone excess in patients with primary aldosteronism and concomitant mild autonomous cortisol secretion (PA+MACS） (time frame: From enrollment to 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.