Aldosterone-Producing Adenoma
Conditions
Keywords
Hypertension, Hypokalemia, Adrenal adenoma
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.
Interventions
DIAGNOSTIC_TESTCXCR4
Participants diagnosed with PA will be asked to be scanned by 68Ga-PentixaFor PET imaging.
Sponsors
Zhongnan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| renin | immediately after admission | measure the level of renin in blood |
| aldosterone | immediately after admission | measure the level of aldosterone in blood |
| SUVmax | immediately after 68Ga-PentixaFor PET imaging | measure the maximum standardized uptake value of adrenal adenoma, liver, and lateral normal adrenal |
| 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 |
| positive predictive value,PPV | immediately after pathological examination | the PPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA |
| negative predictive value, NPV | immediately after pathological examination | the NPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA |
Countries
China
Contacts
Primary ContactZhe Meng
Outcome results
None listed