CXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis

Not Applicable

Recruiting

• Conditions: Aldosterone-Producing Adenoma
• Interventions: Diagnostic Test: CXCR4

• Registration Number: NCT05839483
• Lead Sponsor: Zhongnan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-04-20
• Study First Posted: 2023-05-03
• Study Start: 2023-05-30
• Last Update Submitted: 2023-07-14
• Last Update Posted: 2023-07-17
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CXCR4	CXCR4	scanned by 68Ga-PentixaFor PET imaging

Primary Outcome Measures

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

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China