[18F]AlF-NOTA-pentixather PET/CT in Patients With Suspected Primary Hyperaldosteronism

The study was proposed to include 20 patients with clinical suspicion of primary aldosteronism for [18F]AlF-NOTA-pentixather PET/CT imaging and to analyze the specificity and sensitivity of [18F]AlF-NOTA-pentixather PET/CT for the diagnosis of APA by comparison with the final pathological findings.

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Key information

Conditions

Primary Hyperaldosteronism Adrenal Cortex Diseases Adrenal Cortex Neoplasms Adrenal Gland Diseases Adrenal Gland Neoplasms Adrenocortical Adenoma Adrenocortical Hyperfunction Aldosterone-Producing Adenoma Endocrine Gland Neoplasms Endocrine System Diseases Hyperaldosteronism Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sichuan Academy of Medical Sciences.Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Persistent hypertension or refractory hypertension (blood pressure >140/90 mmHg with a combination of three antihypertensive drugs, including diuretics) with hypokalemia of blood pressure >160/100 mmHg.
Uncontrollable hypokalemia with or without hypertension. Persistent hypertension or refractory hypertension with blood pressure >160/100 mmHg and aldosterone-renin ratio (ARR) ≥30 (ng/dl)/(ng/ml/h).
Positive captopril test (≤30% decrease in plasma aldosterone level after captopril administration) is a sufficient but not mandatory condition.
Patients with CT showing unilateral or bilateral adrenal nodules with well-defined borders but normal serum potassium and ARR <30 (ng/dl)/(ng/ml/h) were also included in the study.

Exclusion criteria

Female patients who are pregnant (or intend to become pregnant within six months), breastfeeding, or unwilling to use contraception.
Abnormal cardiopulmonary function or mental status, unable to tolerate prone for 20 minutes.
Refusal to sign an informed consent form or inability or unwillingness to comply with the investigator-approved study protocol.
Other conditions deemed by the investigator to be inappropriate for participation in this study.

Treatment and study plan

[18F]AlF-NOTA-pentixather PET/CT

Diagnostic Test

The radiotracer 18F-AlF-NOTA-pentixather PET/CT (dose 4.81 MBq/Kg body weight) was injected intravenously according to the patient's body weight. The whole-body PET/CT examination from the top of the skull to the root of the thigh was performed using a PET/CT examination instrument (Siemens Biograph mCT Flow) 50-60 minutes after the injection of radiopharmaceuticals. Flow Motion flow scanning technology with a matrix of 128x128 and a layer thickness of 3 mm was used. all PET images were iteratively reconstructed. Patients who have undergone surgery routinely undergo pathological examination.

Other names: pathological examination

Primary outcomes

Maximum standardized uptake value(SUVmax)

Time frame: Within a week of completion of imaging

Maximum standardized uptake value of suspicious adrenal lesion on [18F]AlF-NOTA-pentixather PET/CT
target background ratio(TBR)

Time frame: Within a week of completion of imaging

The ratio of SUVmax of adrenal lesions to SUVmean of the liver background and the ratio of SUVmax of adrenal lesions to SUVmean of the contralateral adrenal gland were analyzed in the study as the target background ratio(TBR).

Sponsors and collaborators

Lead sponsor

Sichuan Provincial People's Hospital

Other

Registry information

Official study title

Clinical Study of Chemokine Receptor 4 (CXCR4)-Mediated Precision Targeting of 18F for the Diagnosis of Aldosteronism in Primary Aldosteronism

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Apr 18, 2023
Registry last updated: Aug 18, 2026

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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