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CXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis

Z

Zhongnan Hospital

Status

Enrolling

Conditions

Aldosterone-Producing Adenoma

Treatments

Diagnostic Test: CXCR4

Study type

Interventional

Funder types

Other

Identifiers

NCT05839483
Zhe Meng

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

CXCR4
Experimental group
Description:
scanned by 68Ga-PentixaFor PET imaging
Treatment:
Diagnostic Test: CXCR4

Trial contacts and locations

1

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Central trial contact

Zhe Meng

Data sourced from clinicaltrials.gov

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