Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion
Conditions
Brief 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 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.
Interventions
None listed
Sponsors
Peking University First Hospital
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| 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 |
Countries
China
Contacts
CONTACTBaojiang Wu Wu
Outcome results
None listed