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

Qifu Li

Status: Enrolling

Conditions: Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion

Treatments: Diagnostic Test: 68Ga-Pentixafor PET/CT

Study type: Observational

Funder types: Other

Identifiers

NCT06635993

ABOARD study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.