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

NCT06756737 | Not Yet Recruiting DMC

• 1 other identifier: SHE-2024089
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this observational study is to utilize the advantages of 68Ga-Pentixafor subtyping diagnosis and the diagnostic ability of 68Ga-FAPI-04 for cardiovascular disease to identify primary aldosterone patients in need of adrenal surgery using non-invasive methods, while also assessing the degree of myocardial injury. Providing new, simple, and comprehensive diagnostic approaches for patients with primary aldosteronism, and improving the accuracy of clinical decision-making, can help develop personalized treatment plans in the early stages, thereby improving the long-term prognosis of primary aldosteronism patients.

Conditions

Primary Aldosteronism

Keywords

PET/CMR; Primary aldosteronism

Outcome Measures

Primary Outcomes (5)

• positive lesion of adrenal gland

  The first step is to visually evaluate the image by comparing the tracer uptake of adrenal lesions with adjacent and contralateral adrenal tissues. The evaluation results are as follows: ① PET-positive lesions: Adrenal lesions with significantly higher levels of radioactive uptake than normal adrenal tissue; ② PET-negative lesions: Adrenal lesions with similar or lower levels of radioactive uptake compared to normal adrenal tissue. If the bilateral adrenal glands show multiple nodular thickening without obvious normal adrenal tissue, the radiation level in the non-nodular thickening area can be used as a reference. If there are focal adrenal nodules with increased radioactive uptake, it is still considered a positive lesion.

  After the patient signs the informed consent form and completes the scan, an average of 2 days.

• Calculate standardized uptake value on 68Ga-Pentixafor PET

  In PET/MR imaging, the first step is to identify the adrenal lesion area based on morphological characteristics. Using the reconstruction software from United Imaging, I delineate the region of interest (ROI) within the adrenal lesion area. Additionally, I outline the ROI for normal liver tissue and other normal tissues in the body. The liver ROI is defined as a sphere with a diameter of 2 centimeters, typically selected from the liver tissue at the same level as the right adrenal gland. The ROI for normal adrenal tissue is a sphere with a diameter of 0.6 to 0.8 centimeters, with the contralateral normal adrenal tissue being the primary choice, followed by the ipsilateral normal adrenal tissue. Non-nodular areas of adrenal thickening are only considered when no normal adrenal tissue is available. Subsequently, the software automatically generates the maximum standardized uptake value (SUVmax) for the adrenal lesion, the mean standardized uptake value (SUVmean) for normal liver tissue.

  After the patient signs the informed consent form and completes the scan, an average of 2 days.

• Left ventricular ejection fraction（LVEF）

  Analyzing LVEF on CMR images.

  After the patient signs the informed consent form and completes the scan, an average of 2 days.

• systolic wall thickening(Δ T%)

  Analyzing the thickening rate of the ventricular wall in each segment of the myocardium.

  After the patient signs the informed consent form and completes the scan, an average of 2 days.

• Calculate maximum standardized uptake value of the heart on 68Ga-FAPI-04 PET

  Use the American Heart Association's 17 segment method to evaluate for increased radioactive uptake in each segment of myocardium, record the number of positive uptake segments, then delineate the ROI value and calculate SUVmax.

  After the patient signs the informed consent form and completes the scan, an average of 2 days.

Study Arms (2)

Research group

This study aims to recruit 30 patients with primary aldosteronism.

Control group

The study included 30 patients with primary hypertension as the control group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who meet the inclusion and exclusion criteria and are willing to follow the research process.

You may qualify if:

• 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).
• 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.
• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Shanghai East Hospital: lead

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Central Study Contacts

Jie Ding Ding, MD.

CONTACT

086-38804518; dingjie940406@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: January 3, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share