Clinical trial NCT05815069: [18F]AlF-NOTA-pentixather PET/CT in Patients With Suspected Primary Hyperaldosteronism
Official title: Clinical Study of Chemokine Receptor 4 (CXCR4)-Mediated Precision Targeting of 18F for the Diagnosis of Aldosteronism in Primary Aldosteronism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aldosterone-Producing Adenoma
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum standardized uptake value(SUVmax)
timeFrame: Within a week of completion of imaging
measure: target background ratio(TBR)
timeFrame: Within a week of completion of imaging
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences.Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
affiliation: Sichuan Academy of Medical Sciences
name: Wei Zhang, Ph.D
role: STUDY_CHAIR
References:
citation: Ding 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.
citation: Poschenrieder 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.
citation: Heinze 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.