Outcome of 68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Primary Aldosteronism (GAPA)

Qifu Li

Status: Enrolling

Conditions: Primary Aldosteronism

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06238232

GAPA study

Details and patient eligibility

About

To compare the 68Ga-Pentixafor PET/CT and adrenal vein sampling on the long-term outcomes of primary aldosteronism (PA) patients with adrenal nodule (≥1cm)

Full description

This is a randomized study involving patients with primary aldosteronism (PA) patients with adrenal nodule (≥1cm) who completed AVS or 68Ga-Pentixafor PET/CT.We will enroll 320 PA patients with adrenal nodule (≥1cm) .All paticipants will be randomized into 68Ga-Pentixafor PET/CT group(Intervention group) and AVS group(Control group) to compare the long-term outcomes of patients with PA.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

(1)Getting the written informed consent (2)ARR ≥20 (pg/ml)/ (μIU/ml) or ARR ≥ 30(ng/dL)/(ng/ml/hr) plus at least one positive PA confirmatory test (CCT, SSIT).

(3)Patients who are willing to undergo surgery. (4)Patients with hypertension aged 18-70 years. (5)CT or MRI scan of the adrenal glands with nodule (≥1cm). Exclusion criteria

1. Combined with autonomous cortisol secretion, cortisol after 1mg dexamethasone suppression test (DST) ≥50 nmol/l.
2. 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]
3. Suspicion of familial hyperaldosteronism or Liddle syndrome. [i.e., age <20 years, hypertension and hypokalemia, or with family history]
4. Suspicion of pheochromocytoma or adrenal carcinoma.
5. Patients with actively malignant tumor.
6. Patients who have adrenalectomy history or with adrenocortical insufficiency.
7. Long-term use of glucocorticoids.
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) or Underweight (BMI≤18 kg/m²); Untreated aneurysm; Other comorbidity potentially interfering with treatment

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

320 participants in 2 patient groups

68Ga-Pentixafor PET/CT group

Experimental group

Description:

Patients divided into 68Ga-Pentixafor PET/CT group need to undergo 68Ga-Pentixafor PET/CT examination and guide subsequent treatment based on the results

Treatment:

Diagnostic Test: 68Ga-Pentixafor PET/CT

AVS group

No Intervention group

Description:

Patients divided into AVS group need to undergo AVS to guide subsequent treatment based on the results