Aldosterone-Producing Adenoma, Primary Hyperaldosteronism
Conditions
Brief summary
The study was proposed to include 20 patients with clinical suspicion of primary aldosteronism for \[18F\]AlF-NOTA-pentixather PET/CT imaging and to analyze the specificity and sensitivity of \[18F\]AlF-NOTA-pentixather PET/CT for the diagnosis of APA by comparison with the final pathological findings.
Interventions
DIAGNOSTIC_TEST[18F]AlF-NOTA-pentixather PET/CT
The radiotracer 18F-AlF-NOTA-pentixather PET/CT (dose 4.81 MBq/Kg body weight) was injected intravenously according to the patient's body weight. The whole-body PET/CT examination from the top of the skull to the root of the thigh was performed using a PET/CT examination instrument (Siemens Biograph mCT Flow) 50-60 minutes after the injection of radiopharmaceuticals. Flow Motion flow scanning technology with a matrix of 128x128 and a layer thickness of 3 mm was used. all PET images were iteratively reconstructed. Patients who have undergone surgery routinely undergo pathological examination.
Sponsors
Sichuan Provincial People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Persistent hypertension or refractory hypertension (blood pressure \>140/90 mmHg with a combination of three antihypertensive drugs, including diuretics) with hypokalemia of blood pressure \>160/100 mmHg. * Uncontrollable hypokalemia with or without hypertension. Persistent hypertension or refractory hypertension with blood pressure \>160/100 mmHg and aldosterone-renin ratio (ARR) ≥30 (ng/dl)/(ng/ml/h). * Positive captopril test (≤30% decrease in plasma aldosterone level after captopril administration) is a sufficient but not mandatory condition. * Patients with CT showing unilateral or bilateral adrenal nodules with well-defined borders but normal serum potassium and ARR \<30 (ng/dl)/(ng/ml/h) were also included in the study.
Exclusion criteria
* Female patients who are pregnant (or intend to become pregnant within six months), breastfeeding, or unwilling to use contraception. * Abnormal cardiopulmonary function or mental status, unable to tolerate prone for 20 minutes. * Refusal to sign an informed consent form or inability or unwillingness to comply with the investigator-approved study protocol. * Other conditions deemed by the investigator to be inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum standardized uptake value(SUVmax) | Within a week of completion of imaging | Maximum standardized uptake value of suspicious adrenal lesion on \[18F\]AlF-NOTA-pentixather PET/CT |
| target background ratio(TBR) | Within a week of completion of imaging | The ratio of SUVmax of adrenal lesions to SUVmean of the liver background and the ratio of SUVmax of adrenal lesions to SUVmean of the contralateral adrenal gland were analyzed in the study as the target background ratio(TBR). |
Countries
China
Contacts
STUDY_CHAIRWei Zhang, Ph.D
Sichuan Academy of Medical Sciences
Outcome results
None listed