Using CXCR4 PET imaging to diagnose primary aldosteronism

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

This study is testing if a special type of imaging called CXCR4 PET can help doctors diagnose primary aldosteronism in patients who might have this condition.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (Academic / other)
• Locations: 1 site (Chongqing, Chongqing)
• Trial ID: NCT06183554 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of CXCR4 positron emission tomography (PET) imaging in diagnosing primary aldosteronism (PA) in patients suspected of having this condition. It involves recording the disease course, laboratory tests, and adrenal vein sampling results. The study will analyze PET images to assess various indicators, including the maximum standardized uptake value of lesions and their ratios to normal tissues. Additionally, pathological analyses will be performed to investigate specific protein expressions related to aldosterone production.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with persistent or refractory hypertension and specific laboratory findings suggestive of primary aldosteronism.

Not a fit: Patients with familial hyperaldosteronism, adrenocortical carcinoma, or severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate diagnoses of primary aldosteronism, allowing for better-targeted treatments.

How similar studies have performed: While the use of PET imaging in this context is innovative, similar imaging techniques have shown promise in other conditions, suggesting potential for success.

Eligibility criteria

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.

Where this trial is running

Chongqing, Chongqing

• Department of Nuclear Medicine, Daping Hospital of Army Medical University — Chongqing, Chongqing, China (Recruiting)

Study contacts

• Principal investigator: Xiao Chen, Ph.D — Daping Hospital, Army Medical University
• Study coordinator: Xiao Chen, Ph.D

Conditions Primary Aldosteronism