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[18F] AldoView PET/CT Imaging for Primary Aldosteronism Subtyping (FAAST): A Multicenter Diagnostic Test Study

[18F] AldoView PET/CT Imaging for Primary Aldosteronism Subtyping (FAAST): A Multicenter Diagnostic Test Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097279
Enrollment
Unknown
Registered
2025-02-17
Start date
2025-02-26
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary aldosteronism

Interventions

Gold Standard:adrenal vein sampling and PASO outcome
Index test:[18F] AldoView PET/CT

Sponsors

Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1 . age > 18 years ; 2 . Understand the whole process of the experiment, volunteer to participate in the study and sign the informed consent ; 3 . The diagnosis of PA : screening positive, that is, standing plasma aldosterone / renin ratio, ARR >= 20 ( pg / ml ) / ( µIU / ml ) or ARR >= 30 ( ng / dL ) / ( ng / ml / hr ) and at least one diagnostic test was positive ( plasma aldosterone >= 110pg / ml after captopril inhibition test ( CCT ) or plasma aldosterone >= 100pg / ml after sitting saline load test ( SIT ) ) ; 4 . CT or MRI imaging examinations suggest that there are clear or suspicious lesions in the adrenal gland, which can be manifested as adrenal nodules or thickening of the adrenal gland.

Exclusion criteria

Exclusion criteria: 1 .Refuse to join the test, the patient or close relatives can not understand or sign the informed consent ; 2 . patients with other common secondary hypertension, such as renal artery stenosis, renal parenchymal hypertension, pheochromocytoma, hypercortisolism, etc; 3. Complicated with malignant tumor or severe heart, lung, kidney and liver dysfunction ; 4. pregnant or lactating women, women with pregnancy plans during the trial period, and women at high risk of pregnancy who have not taken any contraceptive measures ; 5. had undergone adrenal surgery ; 6 . Patients with adrenocortical dysfunction requiring hormone replacement therapy ; 7.Long-term use of glucocorticoids and can not be discontinued.

Design outcomes

Primary

MeasureTime frame
The sensitivity and specificity of classification diagnosis;Percentage of biochemical complete remission;

Secondary

MeasureTime frame
Proportion of clinical complete remission;Changes in Systolic blood pressure;The number of antihypertensive drugs reduced;The cure rate of hypertension;The accuracy of the prediction model for PA classification diagnosis;Predicting the accuracy of postoperative pathology;

Countries

China

Contacts

Public ContactLuo Xianghang; Jiang Tiejian

Xiangya Hospital of Central South University

xianghangluo@hotmail.com+86 139 7589 9012

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026