CXCR4 Targeted PET Imaging in the Diagnosis and Identification of Primary Aldosteronism

Primary Aldosteronism Clinical Trial

Official title:

CXCR4 Targeted PET Imaging in the Diagnosis and Identification of Primary Aldosteronism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06183554
• Other study ID #: 2023239
• Status: Recruiting
• Start date: August 31, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: December 2023
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Xiao Chen, Ph.D
• Phone: +8615922970174
• Email: xiaochen229[@]foxmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aimed to prospectively evaluate the utility of C-X-C chemokine receptor type 4 (CXCR4) positron emission tomography (PET) imaging in patients with clinical suspected primary aldosteronism (PA), with postoperative pathological or follow-up results as reference standards.

Description:

1. Record the course of disease, the laboratory examination (e.g., potassium, aldosterone, aldosterone-to-renin ratio, intravenous salt-loading test or captopril test) and the results of adrenal vein sampling in patients with clinically suspected PA.

2. PET image analysis: Record and evaluate the following indicators: the maximum standardized uptake value (SUVmax) of lesions, the mean standardized uptake value (SUVmean) of normal liver, the SUVmean of adjacent normal adrenal tissue, the ratio of the lesional SUVmax to the normal liver SUVmean (LLR), and the ratio of the lesional SUVmax to the adjacent adrenal tissue SUVmean (LAR).

3. Pathological analysis: Hematoxylin and eosin staining and immunohistochemical analyses will be performed. Immunohistochemical analysis will be used to investigate the expression of aldosterone synthase (CYP11B2) and CXCR4.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Persistent hypertension with blood pressure > 150/100 mmHg, refractory hypertension (blood pressure >140/90 mmHg with combined use of three types of antihypertensive medications, including diuretics), or with hypokalemia of blood pressure >140/90 mmHg;

2. Refractory hypertension with an aldosterone-to-renin ratio (ARR) = 2.0 (ng/dl)/(mU/L);

3. Positive intravenous salt-loading test or captopril test;

4. Hypertension and adrenal lesions;

5. Patient =18 years of age at the time of consent;

6. Provided written informed consent authorisation before participating in the study.

Exclusion Criteria:

1. Refusal by the patients to undergo CXCR4 PET imaging, adrenal vein sampling, superselective adrenal arterial embolization or adrenalectomy;

2. Suspicion of familial hyperaldosteronism type 1 (FH-1) or type 3 (FH-3);

3. Suspicion of adrenocortical carcinoma;

4. Severe comorbidity potentially interfering with treatment or HRQoL;

5. Requirement of medication interfering with the study protocol;

6. Pregnancy or lactation;

7. Estimated glomerular filtration rate <40 mL/min/1.73 m².

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Aldosteronism

Intervention

Diagnostic Test:
• CXCR4
Patients with clinical suspected primary aldosteronism will receive a CXCR4 PET imaging.

Locations

Country	Name	City	State
China	Department of Nuclear Medicine, Daping Hospital of Army Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Xiao Chen

Country where clinical trial is conducted

China, 

References & Publications (1)

Hu J, Xu T, Shen H, Song Y, Yang J, Zhang A, Ding H, Xing N, Li Z, Qiu L, Ma L, Yang Y, Feng Z, Du Z, He W, Sun Y, Cai J, Li Q, Chen Y, Yang S; Chongqing Primary Aldosteronism Study (CONPASS) Group. Accuracy of Gallium-68 Pentixafor Positron Emission Tomography-Computed Tomography for Subtyping Diagnosis of Primary Aldosteronism. JAMA Netw Open. 2023 Feb 1;6(2):e2255609. doi: 10.1001/jamanetworkopen.2022.55609. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardised uptake values	Standardised uptake values of suspected adrenal disease in CXCR4 PET imaging	completed within one week after the PET examination
Secondary	Immunohistochemical results	Immunohistochemical evaluation of postoperative adrenal specimens	completed within one week after surgery