68Ga-Pentixafor PET/CT for the Subtyping Diagnosis of Primary Aldosteronism

Qifu Li

Status: Completed

Conditions: Primary Aldosteronism

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

Study type: Observational

Funder types: Other

Identifiers

NCT05131061

2021-553

Details and patient eligibility

About

To evaluate the value of 68Ga-Pentixafor PET/CT in the diagnosis of primary aldosteronism subtype

Full description

This is a prospective study. We will enroll 100 patients with definite diagnosis of PA using adrenal venous sampling(AVS) as the gold standard for subtype to evaluate the value of 68Ga-pentixaforPET/CT in the diagnosis of PA.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. PA diagnosis confirmed by at least one confirmatory test
2. willingness to undergo AVS and surgery
3. informed consent to participate in the study.

Exclusion criteria

1. PA patients who met guideline criteria for bypassing AVS [i.e. younger than 35 years old, with typical APA characteristics (plasma aldosterone >300pg/ml, plasma renin < 2·5mIU/l, serum potassium <3·5mmol/l, CT indicated unilateral 1cm low-density adenoma);
2. failed adrenal vein cannulation during AVS;
3. Subtyping diagnosis was inconclusive based on AVS results (e.g. aldosterone/cortisol ratio in bilateral adrenal veins lower than the peripheral vein, or missing data);
4. pregnant or lactating women;
5. patients with a history of uncontrolled malignant tumor;
6. concurrent Cushing's syndrome [including mild autonomous cortisol secretion: cortisol after 1mg dexamethasone suppression test (DST)>138 nmol/l or cortisol after 2mg DST >50 nmol/l or cortisol after 1mg DST 50-138 nmol/l plus adrenocorticotrophic hormone (ACTH)<10pg/ml;
7. diagnosis of familial hyperaldosteronism;
8. imaging characteristics suggestive of pheochromocytoma or adrenal cortical carcinoma;
9. unsuitable for surgery, such as heart failure with New York Heart Association (NYHA) class III or IV, severe anemia (Hemoglobin<60g/L), stroke or acute coronary syndrome within 3 months, severe ascites and cirrhosis, estimated glomerulus filtration rate<30ml/min/m;
10. alcohol or drug abuse and mental disorders.

Trial design

100 participants in 2 patient groups

unilateral primary aldosteronism(UPA)

Description:

PA confirmatory tests was positive; successful intubation (SI ≥ 3) and LI ≥ 4; If LI between 2 and 4, should be combined with contralateral inhibition index \< 1 or CT indicate typical adenomas on the dominant side.

Treatment:

Diagnostic Test: 68Ga-Pentixafor PET/CT imaging

bilateral adrenal hyperplasia(BAH)

Description:

PA confirmatory tests was positive; successful intubation (SI ≥ 3) and LI \< 2; or LI between 2 and 4 but does not meet the UPA conditions

Treatment:

Diagnostic Test: 68Ga-Pentixafor PET/CT imaging