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

Recruitingn/aAges 18 Years - 80 YearsAllPeking University First Hospital
NCT07605156 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 determi

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
Peking University First Hospital, Beijing
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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