Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion
Conditions
Keywords
primary aldosteronism, autonomous cortisol secretion, Adrenal venous sampling, 68Ga-Pentixafor PET/CT
Brief 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.
Detailed description
This study is a multicenter, prospective, diagnostic trial involving patients with primary aldosteronism (PA) concurrent with autonomous cortisol secretion (ACS) patients with adrenal nodule (≥1cm) who completed both AVS and 68Ga-Pentixafor PET/CT. We will enroll 97 PA concurrent with ACS patients with adrenal nodule (≥1cm) .The treatment plan was determined according to the AVS results. AVS and/or postoperative remission were used as the reference standard for classification diagnosis to evaluate the accuracy of 68Ga-Pentixafor PET-CT in the classification diagnosis of PA concurrent with ACS patients.
Interventions
DIAGNOSTIC_TEST68Ga-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.
Sponsors
The First Affiliated Hospital of Zhengzhou University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The Third Xiangya Hospital of Central South University
The Affiliated Hospital Of Southwest Medical University
Qifu Li
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the accuracy of 68Ga-Pentixafor PET-CT in the classification diagnosis of PA concurrent with ACS patient | 6 months | 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. |
Countries
China
Contacts
Primary ContactQi fu Li, PhD
Outcome results
None listed