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

Completed

• Conditions: Primary Aldosteronism
• Interventions: Diagnostic Test: 68Ga-Pentixafor PET/CT imaging

• Registration Number: NCT05131061
• Lead Sponsor: Qifu Li

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-11-11
• Study First Submitted: 2021-11-11
• Study First Submitted QC: 2021-11-11
• Study First Posted: 2021-11-23
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
unilateral primary aldosteronism(UPA)	68Ga-Pentixafor PET/CT imaging	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.
bilateral adrenal hyperplasia(BAH)	68Ga-Pentixafor PET/CT imaging	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

Primary Outcome Measures

Name	Time	Method
accuracy of 68Ga-PentixaforPET/CT in subtyping diagnosis of PA	at the end of study(the last enrolled patient completed a 3-month follow-up)	AUC

Trial Locations

Locations (1)

The First Affilated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China