Clinical trial NCT06635993: Accuracy of 68Ga-Pentixafor PET/CT for Subtypting Diagnosis in Patients With Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion
Official title: Accuracy of 68Ga-Pentixafor PET/CT for Subtypting Diagnosis in Patients With Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion
Keywords: primary aldosteronism
autonomous cortisol secretion
Adrenal venous sampling
68Ga-Pentixafor PET/CT
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Zhengzhou University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: The Third Xiangya Hospital of Central South University
name: The Affiliated Hospital Of Southwest Medical University
First posted: 2024-10-10
Enrollment: 97
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PA concurrent with ACS patients were from The First Affiliated Hospital of Chongqing Medical University, The Affiliated Hospital of Southwest Medical University, The Third Xiangya Hospital of Central South University, The First Affiliated Hospital of Zhengzhou University and Nanjing Drum Tower Hospital.

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.

Eligibility criteria: 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 \[i.e., younger than 35 years old, spontaneous hypokalemia, adrenal CT indicated unilateral low-density adenoma (≥1cm), plasma aldosterone \&amp;gt;300pg/ml\]；
2. Suspicion of familial hyperaldosteronism or Liddle syndrome. \[i.e., age \&amp;lt;20 years, hypertension and hypokalemia, or with family history\]；
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\&lt;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) \&lt;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 outcomes:
measure: the accuracy of 68Ga-Pentixafor PET-CT in the classification diagnosis of PA concurrent with ACS patient
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affilated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: the Chongqing Primary Aldosteronism Study (CONPASS) Group
name: Qi fu Li, PhD
role: STUDY_CHAIR
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