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

68Ga-Pentixafor PET/CT for the Subtyping Diagnosis of Primary Aldosteronism: A Prospective Diagnostic Accuracy Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05131061

Enrollment

100

Registered

2021-11-23

Start date

2021-11-11

Completion date

2022-05-31

Last updated

2022-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Aldosteronism

Keywords

PET CT; Primary aldosteronism; Adrenal venous sampling

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.

Interventions

DIAGNOSTIC_TEST68Ga-Pentixafor PET/CT imaging

68Ga-Pentixafor PET/CT imaging

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026