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

NCT06183554 | Unknown

• 1 other identifier: 2023239
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Aldosteronism

Outcome Measures

Primary Outcomes (1)

• Standardised uptake values

  Standardised uptake values of suspected adrenal disease in CXCR4 PET imaging

  completed within one week after the PET examination

Secondary Outcomes (1)

• Immunohistochemical results

  completed within one week after surgery

Interventions

CXCR4 DIAGNOSTIC_TEST

Patients with clinical suspected primary aldosteronism will receive a CXCR4 PET imaging.

Eligibility Criteria

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

Study Population

The subjects the investigators selected are adults who are not restricted by gender.

You may qualify if:

• 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;
• Refractory hypertension with an aldosterone-to-renin ratio (ARR) ≥ 2.0 (ng/dl)/(mU/L);
• Positive intravenous salt-loading test or captopril test;
• Hypertension and adrenal lesions;
• Patient ≥18 years of age at the time of consent;
• Provided written informed consent authorisation before participating in the study.

You may not qualify if:

• Refusal by the patients to undergo CXCR4 PET imaging, adrenal vein sampling, superselective adrenal arterial embolization or adrenalectomy;
• Suspicion of familial hyperaldosteronism type 1 (FH-1) or type 3 (FH-3)；
• Suspicion of adrenocortical carcinoma；
• Severe comorbidity potentially interfering with treatment or HRQoL；
• Requirement of medication interfering with the study protocol；
• Pregnancy or lactation；
• Estimated glomerular filtration rate \<40 mL/min/1.73 m².

Sponsors & Collaborators

• Xiao Chen: lead

Study Sites (1)

Department of Nuclear Medicine, Daping Hospital of Army Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

Related 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.

  PMID: 36795418 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

adrenal resection specimens

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Xiao Chen, Ph.D

  Daping Hospital, Army Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Chen, Ph.D

CONTACT

+8615922970174; xiaochen229@foxmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Nuclear Medicine Department

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 27, 2023
• Study Start: August 31, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)