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NCT Number: NCT05131061

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affilated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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);
  • failed adrenal vein cannulation during AVS;
  • 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);
  • pregnant or lactating women;
  • patients with a history of uncontrolled malignant tumor;
  • 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;
  • diagnosis of familial hyperaldosteronism;
  • imaging characteristics suggestive of pheochromocytoma or adrenal cortical carcinoma;
  • 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;
  • alcohol or drug abuse and mental disorders.

Treatment and study plan

68Ga-Pentixafor PET/CT imaging

Diagnostic Test

68Ga-Pentixafor PET/CT imaging

Primary outcomes

  1. accuracy of 68Ga-PentixaforPET/CT in subtyping diagnosis of PA

    Time frame: at the end of study(the last enrolled patient completed a 3-month follow-up)

    AUC

Sponsors and collaborators

Lead sponsor

Qifu Li

Other

Collaborators

  • The Affiliated Hospital Of Southwest Medical University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 23, 2021
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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