The Application of 68Ga-Pentixafor Alongside 68Ga-FAPI-04 PET/MR for Assessing Primary Aldosteronism.

Launched by SHANGHAI EAST HOSPITAL · Dec 26, 2024

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ClinConnect Summary

This clinical trial is studying a new way to diagnose primary aldosteronism, a condition that can cause high blood pressure due to an excess of the hormone aldosterone. Researchers want to see if using two imaging techniques, called 68Ga-Pentixafor and 68Ga-FAPI-04 PET/MR, can help identify patients who might need surgery to treat their condition and assess any potential heart damage. The goal is to find easier and more accurate ways to diagnose this condition early, which could lead to better treatment plans and improved health outcomes for patients.

To participate in this study, you must be over 18 and have been diagnosed with primary aldosteronism based on specific medical criteria, such as having high blood pressure that doesn’t respond to treatment or abnormal hormone levels. If you join the study, you can expect to undergo some non-invasive imaging tests and heart evaluations to gather important information about your condition. It's important to note that this trial is not yet recruiting participants, so more information will be shared when it starts.

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Eligibility criteria

• Inclusion Criteria:
• • Research Group Inclusion Criteria - (1) Patients must be over 18 years of age. (2) Patients diagnosed by an endocrinologist as highly suspected or confirmed cases of primary aldosteronism according to the guidelines of the Endocrine Society will be included.
• 1. The criteria for high suspicion are as follows:
• • ① Persistent hypertension \>160/100 mmHg, especially resistant hypertension (blood pressure remains \>140/90 mmHg despite treatment with three or more antihypertensive medications) accompanied by hypokalemia (serum potassium concentration \<3.5 mmol/L); or ② Drug-resistant hypokalemia with or without hypertension; or ③ Persistent hypertension with plasma aldosterone concentration (PAC) \>15 ng/dl and a plasma aldosterone-renin ratio (ARR) ≥30 (ng/dl)/(ng/ml/h) (when plasma renin activity \<0.1 ng/ml/h, it is calculated as 0.1 ng/ml/h).
• 2. The criteria for confirming primary aldosteronism are as follows:
• Under the conditions of high suspicion, a positive result from the captopril challenge test (CCT) must be met. The principles, examination process, and methods for positive assessment of the CCT are as follows:
• • Principle: Captopril is an angiotensin-converting enzyme inhibitor that can suppress the renin-angiotensin-aldosterone system in normal individuals, thereby reducing aldosterone secretion. However, it has no significant inhibitory effect on patients with autonomous aldosterone secretion, such as those with primary aldosteronism.
• • Examination method: Discontinue aldosterone antagonists and angiotensin-converting enzyme inhibitors for 1-2 weeks. On the day of the test, the patient should remain seated or supine for at least 4 hours, then orally administer 25 mg of captopril, and maintain the same position for 2 hours before drawing blood to measure PAC and PRA levels.
• • Evaluation of test results: Calculate the change rate of PAC before and after the test, as well as the ARR value after the test. Based on published data, a reduction in PAC of \<30% compared to pre-test levels or an ARR value \>46.2 after the CCT is considered a diagnostic threshold for a positive test result.
• • (3) Imaging studies indicate the presence of unilateral or bilateral adrenal nodules or nodular hyperplasia in the patient.
• • (4) Prior to enrollment, patients will undergo echocardiography, and the results will be recorded. If left ventricular hypertrophy is indicated, the patient will be included in the primary aldosteronism group with myocardial hypertrophy; otherwise, they will be included in the primary aldosteronism group without myocardial hypertrophy. Control Group Inclusion Criteria (1) The patient is over 18 years of age.
• • (2) The systolic blood pressure is greater than or equal to 140 mmHg or the diastolic blood pressure is greater than or equal to 90 mmHg.
• • (3) The patient's biochemical tests indicate normal adrenal hormone secretion. (4) There are no identifiable causes of secondary hypertension. (5) Imaging studies suggest the presence of unilateral or bilateral adrenal nodules or nodular hyperplasia in the patient.
• • (6) the patient undergoes a cardiac ultrasound before enrollment, and the results are recorded. If the ultrasound indicates left ventricular hypertrophy, the patient is included in the primary hypertension group with myocardial hypertrophy; otherwise, they are included in the primary hypertension group without myocardial hypertrophy.
• Exclusion Criteria:
• • (1) Children, pregnant and lactating women, etc; (2) Patients with poor autonomous behavioral ability (such as inability to lie flat), severe claustrophobia, and critically ill patients requiring life support who are unable to cooperate in completing the examination; (3) Patients with severe liver and kidney failure; (4) Patients with a history of myocardial infarction, cardiomyopathy, myocarditis, or congenital heart disease in the past; (5) Patients who can not successfully undergo CMR examination, such as arrhythmia or inability to hold their breath. (6) Patients with other conditions that are not suitable for this examination.