Clinical trial · Interventional
[18F]AlF-NOTA-pentixather PET/CT in Patients With Suspected Primary Hyperaldosteronism
Clinical Study of Chemokine Receptor 4 (CXCR4)-Mediated Precision Targeting of 18F for the Diagnosis of Aldosteronism in Primary Aldosteronism
NCT05815069CI-TRIAL-00122593completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aldosterone-Producing Adenoma | — | UNRESOLVED | — |
| Primary Hyperaldosteronism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]AlF-NOTA-pentixather PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [18F]AlF-NOTA-pentixather
- description
- No special preparation such as fasting and fasting is required before the examination. The radiotracer 18F-AlF-NOTA-pentiaxther PET/CT (dose 4.81 MBq/Kg body weight) was injected intravenously according to the patient's body weight, and the drug was synthesized by the Department of Nuclear Medicine of Sichuan Provincial People's Hospital immediately before the examination. Before the examination, patients were instructed to urinate as many times as possible to reduce the possible influence of the residual radiotracer in the renal pelvis and calyces on the image quality. 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 reconstructed iteratively.
- interventionNames
- Diagnostic Test: [18F]AlF-NOTA-pentixather PET/CT
Primary outcomes (2)
- measure
- Maximum standardized uptake value(SUVmax)
- timeFrame
- Within a week of completion of imaging
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (3)
- RESULTDing J, Zhang Y, Wen J, Zhang H, Wang H, Luo Y, Pan Q, Zhu W, Wang X, Yao S, Kreissl MC, Hacker M, Tong A, Huo L, Li X. Imaging CXCR4 expression in patients with suspected primary hyperaldosteronism. Eur J Nucl Med Mol Imaging. 2020 Oct;47(11):2656-2665. doi: 10.1007/s00259-020-04722-0. Epub 2020 Mar 23. PMID 32206838
- RESULTPoschenrieder A, Osl T, Schottelius M, Hoffmann F, Wirtz M, Schwaiger M, Wester HJ. First 18F-Labeled Pentixafor-Based Imaging Agent for PET Imaging of CXCR4 Expression In Vivo. Tomography. 2016 Jun;2(2):85-93. doi: 10.18383/j.tom.2016.00130. PMID 30042959
- RESULTHeinze B, Fuss CT, Mulatero P, Beuschlein F, Reincke M, Mustafa M, Schirbel A, Deutschbein T, Williams TA, Rhayem Y, Quinkler M, Rayes N, Monticone S, Wild V, Gomez-Sanchez CE, Reis AC, Petersenn S, Wester HJ, Kropf S, Fassnacht M, Lang K, Herrmann K, Buck AK, Bluemel C, Hahner S. Targeting CXCR4 (CXC Chemokine Receptor Type 4) for Molecular Imaging of Aldosterone-Producing Adenoma. Hypertension. 2018 Feb;71(2):317-325. doi: 10.1161/HYPERTENSIONAHA.117.09975. Epub 2017 Dec 26. PMID 29279316