About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Combined with autonomous cortisol secretion, cortisol after 1mg dexamethasone suppression test (DST) ≥50 nmol/l.

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]

Suspicion of familial hyperaldosteronism or Liddle syndrome. [i.e., age <20 years, hypertension and hypokalemia, or with family history]

Suspicion of pheochromocytoma or adrenal carcinoma.

Trial design

Design model

Parallel

Treatments tested in this trial

68Ga-Pentixafor PET/CT
Diagnostic test
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.

Treatment groups

320 Participants

are divided into 2 treatment groups

Group A: 68Ga-Pentixafor PET/CT groupExperimental treatment 1 intervention

Group B: AVS groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The proportion of complete biochemical remission

Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria.

Time frame

At 6 months of follow-up.

Secondary outcomes

1

The proportion of complete clinical remission

Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria.

Time frame

At 6 months of follow-up.

2

In surgical population, the proportion of complete biochemical remission

Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria.

Time frame

At 6 months of follow-up.

3

In surgical population, the proportion of complete clinical remission

Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria.

Time frame

At 6 months of follow-up.

4

Daily defined doses (DDD) of antihypertensive agents

Prescribed daily dose (DDD) of antihypertensive drugs (including MRA) in each group after 6-12 months of follow-up.

Time frame

At 6-12 months of follow-up.

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts