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Clinical Trials in China / NCT06635993
Recruiting Observational

Accuracy of 68Ga-Pentixafor PET/CT for Subtypting Diagnosis in Patients With Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion

NCT06635993 · tracked via the Priya Life Science China tracker
Sponsor
Qifu Li
Phase
Observational
Started
2024-08-12
Last updated
2024-10-10

Condition(s) studied

Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion

Investigational drug(s) / intervention(s)

68Ga-Pentixafor PET/CT

68Ga-Pentixafor PET/CT: The patients had a normal diet with no special preparation before 68Ga-Pentixafor PET/CT imaging. The dosage of intravenously injected 68Ga-Pentixafor was calculated based on the patient\'s weight (1.85 MBq \[0.05mCi\]/kg). Local PET/CT scanning of the upper abdomen was performed on a hybrid PET/CT scanner at 10 minutes after the injection of the intravenous tracer, respectively.

Study summary

To evaluate the accuracy of 68Ga-Pentixafor PET-CT in the classification diagnosis of primary aldosteronism concurrent with autonomous cortisol secretion patient, using AVS and/or postoperative remission as the reference standard for classification diagnosis.

Eligibility

Sex
ALL
Min age
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Getting the written informed consent 2. The clear diagnosis of primary aldosteronism; 3. Combined with autonomous cortisol secretion, cortisol after 1mg dexamethasone suppression test (DST) ≥50 nmol/l; 4. Patients who are willing to undergo surgery; 5. Adrenal CT or MRI scan of the adrenal glands with nodule (≥1cm). Exclusion Criteria: 1. PA patients who meet the by-passing AVS criteria \[i.e., younger than 35 years old, spontaneous hypokalemia, adrenal CT indicated unilateral low-density adenoma (≥1cm), plasma aldosterone \>300pg/ml\]; 2. Suspicion of familial hyperaldosteronism or Liddle syndrome. \[i.e., age \<20 years, hypertension and hypokalemia, or with family history\]; 3. Suspicion of pheochromocytoma or adrenal carcinoma; 4. Patients with actively malignant tumor; 5. Patients who have adrenalectomy history; 6. Long-term use of glucocorticoids; 7. Patients who are allergic to contrast media and cannot tolerate AVS; 8. Pregnant or lactating women; with alcohol or drug abuse and mental disorders; 9. Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV; History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 3 months; Severe anemia (Hb\<60g/L); Serious liver dysfunction or chronic kidney disease aspartate aminotransferase (AST) or alanine transaminase (ALT) ≥3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73 m2); Systemic Inflammatory Response Syndrome (SIRS); Uncontrolled diabetes (FBG≥13.3 mmol/L); Obesity (BMI≥35 kg/m²); Untreated aneurysm; Other comorbidity potentially interfering with treatment; 10. Consider patients with bilateral cortisol hypersecretion such as PBMAH or PPNAD.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affilated Hospital of Chongqing Medical University Chongqing Chongqing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06635993 on ClinicalTrials.gov ↗ ← All trials in China