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

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: Recruiting
• Conditions: Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion

• Study Type: Observational
• Enrollment (Estimated): 130

Contacts and Locations

• Study Contact: Name: Baojiang Wu Wu; Phone Number: 01013231338962; Email: 2300736651@qq.com

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

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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）	From enrollment to 12 months postoperatively

Collaborators and Investigators

• Sponsor: Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: May 17, 2026
• First Submitted That Met QC Criteria: May 17, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SFMSSXPETCT