Diagnostic Value of 68Ga-Pentixafor PET/CT in Adrenal Tumors With Aldosterone and Cortisol Cosecretion

May 17, 2026 updated by: Peking University First Hospital

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University First Hospital, Beijing
        • Contact:
          • Peking University First Hospital Peking University First Hospital
          • Phone Number: 01083572418
          • Email: 2300736651@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
From enrollment to 12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SFMSSXPETCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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