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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai East Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 2 trial groups
Group A: Research group
Group B: Control group

Trial outcomes

Primary outcomes

1

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.

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

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.

Time frame
After the patient signs the informed consent form and completes the scan, an average of 2 days.
3

Left ventricular ejection fraction(LVEF)

Analyzing LVEF on CMR images.

Time frame
After the patient signs the informed consent form and completes the scan, an average of 2 days.
4

systolic wall thickening(Δ T%)

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

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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