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

Study Overview
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Brief Summary
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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.

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

Conditions
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Aldosterone-Producing Adenoma

Intervention / Treatment
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* Diagnostic Test: [18F]AlF-NOTA-pentixather PET/CT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [18F]AlF-NOTA-pentixather<br>No special preparation such as fasting and fasting is required before the examination. The radiotracer 18F-AlF-NOTA-pentiaxther PET/CT (dose 4.81 MBq/Kg body weight) was injected intravenously according to the patient's body weight, and the drug was synthesized by the Department of Nuclear Medicine of Sichuan Provincial People's Hospital immediately before the examination. Before the examination, patients were instructed to urinate as many times as possible to reduce the possible influence of the residual radiotracer in the renal pelvis and calyces on the image quality. 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 reconstructed iteratively. | Diagnostic Test: [18F]AlF-NOTA-pentixather PET/CT<br>* 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.<br>* Other names: pathological examination;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum standardized uptake value(SUVmax) | Maximum standardized uptake value of suspicious adrenal lesion on [18F]AlF-NOTA-pentixather PET/CT | Within a week of completion of imaging | 
| target background ratio(TBR) | 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). | Within a week of completion of imaging |