CXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis

A Single Center Study on the Evaluation of Diagnostic Efficacy of CXCR4 Targeted PET Imaging in Primary Aldosteronism

The goal of this clinical trial is to evaluate the effectiveness of CXCR4 targeted PET imaging in preoperative localization diagnosis of primary aldosteronism (PA). Participants diagnosed with PA will be asked to be scanned by 68Ga-PentixaFor PET, and then underwent adrenal venous sampling (AVS). Then, the responsible adrenal adenoma will be resected by adrenalectomy, and examined with pathological section and staining. Researchers will compare the sensitivity and specificity between 68Ga-PentixaFor PET imaging and AVS in preoperative localization diagnosis of PA.

Study Overview

• Status: Recruiting
• Conditions: Aldosterone-Producing Adenoma
• Intervention / Treatment: Diagnostic test: CXCR4

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhe Meng; Phone Number: +86 15387041020; Email: mengzhe@whu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Recruiting
      • Zhongnan Hospital of Wuhan University
      • Contact: Zhe Meng; Phone Number: +86 15387041020

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with PA, confirmed by an elevated aldosterone/renin ratio (ARR) and an intravenous salt loading test.
• The patient has provided written informed consent authorisation before participating in the study.
• The patient is 18 to 70 years of age at the time of consent.

Exclusion Criteria:

• Refusal by the patients to undergo 68Ga-PentixaFor PET/CT, AVS, CT, 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 health-related quality of life.
• Patients need to take drugs that interfere with clinical research.
• Any medical condition present that in the opinion of the investigator will affect patients clinical status.
• Pregnancy or lactation.
• Estimated glomerular filtration rate <40mL/min/1.73m2.
• Interfering treatment in between 68Ga-PentixaFor PET/CT and AVS.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CXCR4; scanned by 68Ga-PentixaFor PET imaging	Diagnostic test: CXCR4; Participants diagnosed with PA will be asked to be scanned by 68Ga-PentixaFor PET imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
renin	measure the level of renin in blood	immediately after admission
aldosterone	measure the level of aldosterone in blood	immediately after admission
SUVmax	measure the maximum standardized uptake value of adrenal adenoma, liver, and lateral normal adrenal	immediately after 68Ga-PentixaFor PET imaging
sensitivity	the sensitivity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA	immediately after pathological examination
specificity	the specificity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA	immediately after pathological examination
positive predictive value,PPV	the PPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA	immediately after pathological examination
negative predictive value, NPV	the NPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA	immediately after pathological examination

Collaborators and Investigators

• Sponsor: Zhongnan Hospital
• Investigators: Principal Investigator: Zhe Meng, Wuhan University

Publications and helpful links

General Publications

• Ding J, Zhang Y, Wen J, Zhang H, Wang H, Luo Y, Pan Q, Zhu W, Wang X, Yao S, Kreissl MC, Hacker M, Tong A, Huo L, Li X. Imaging CXCR4 expression in patients with suspected primary hyperaldosteronism. Eur J Nucl Med Mol Imaging. 2020 Oct;47(11):2656-2665. doi: 10.1007/s00259-020-04722-0. Epub 2020 Mar 23.
• Cui Y, Zhang Y, Ding J, Wang H, Ma X, Wang O, Chang X, Sun H, Huo L, Tong A. A Rare Aldosterone-Producing Adenoma Detected by 68Ga-pentixafor PET-CT: A Case Report and Literature Review. Front Endocrinol (Lausanne). 2019 Nov 29;10:810. doi: 10.3389/fendo.2019.00810. eCollection 2019.
• Chaman Baz AH, van de Wiel E, Groenewoud H, Arntz M, Gotthardt M, Deinum J, Langenhuijsen J. CXCR4-directed [68Ga]Ga-PentixaFor PET/CT versus adrenal vein sampling performance: a study protocol for a randomised two-step controlled diagnoStic Trial Ultimately comparing hypertenSion outcome in primary aldosteronism (CASTUS). BMJ Open. 2022 Aug 23;12(8):e060779. doi: 10.1136/bmjopen-2022-060779.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Hypertension; Hypokalemia; Adrenal adenoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: Zhe Meng

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No