Clinical trial NCT06183554: CXCR4 Targeted PET Imaging in the Diagnosis and Identification of Primary Aldosteronism
Official title: CXCR4 Targeted PET Imaging in the Diagnosis and Identification of Primary Aldosteronism
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Aldosteronism
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects the investigators selected are adults who are not restricted by gender.

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Standardised uptake values
timeFrame: completed within one week after the PET examination
Secondary outcomes:
measure: Immunohistochemical results
timeFrame: completed within one week after surgery
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University
state: Chongqing
Study officials:
affiliation: Daping Hospital, Army Medical University
name: Xiao Chen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.