Clinical trial NCT05839483: CXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis
Official title: A Single Center Study on the Evaluation of Diagnostic Efficacy of CXCR4 Targeted PET Imaging in Primary Aldosteronism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aldosterone-Producing Adenoma
Keywords: Hypertension
Hypokalemia
Adrenal adenoma
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: renin
timeFrame: immediately after admission
measure: aldosterone
timeFrame: immediately after admission
measure: SUVmax
timeFrame: immediately after 68Ga-PentixaFor PET imaging
measure: sensitivity
timeFrame: immediately after pathological examination
measure: specificity
timeFrame: immediately after pathological examination
measure: positive predictive value,PPV
timeFrame: immediately after pathological examination
measure: negative predictive value, NPV
timeFrame: immediately after pathological examination
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Wuhan University
name: Zhe Meng
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cui Y, Zhang Y, Ding J, Wang H, Ma X, Wang O, Chang X, Sun H, Huo L, Tong A. A Rare Aldosterone-Producing Adenoma Detected by 68Ga-pentixafor PET-CT: A Case Report and Literature Review. Front Endocrinol (Lausanne). 2019 Nov 29;10:810. doi: 10.3389/fendo.2019.00810. eCollection 2019.
citation: Chaman Baz AH, van de Wiel E, Groenewoud H, Arntz M, Gotthardt M, Deinum J, Langenhuijsen J. CXCR4-directed [68Ga]Ga-PentixaFor PET/CT versus adrenal vein sampling performance: a study protocol for a randomised two-step controlled diagnoStic Trial Ultimately comparing hypertenSion outcome in primary aldosteronism (CASTUS). BMJ Open. 2022 Aug 23;12(8):e060779. doi: 10.1136/bmjopen-2022-060779.
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.