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Status unknownNCT05839483Updated Jul 17, 2023

CXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis

An interventional study of CXCR4 in Aldosterone-Producing Adenoma, sponsored by Zhongnan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-07-17.

Sponsored by Zhongnan Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

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Conditions studied

  • Aldosterone-Producing Adenoma

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Keywords

  • Hypertension
  • Hypokalemia
  • Adrenal adenoma
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In context

Adenoma

657 studies on the registry are indexed under Adenoma; 98 are open to participants now.

This study's planned enrollment of 50 is below the median of 250 across 412 interventional studies indexed under Adenoma.

Browse Adenoma studies →

Lead sponsor

Zhongnan Hospital is the lead sponsor of 103 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    CXCR4

    scanned by 68Ga-PentixaFor PET imaging

    Diagnostic Test: CXCR4

Interventions

  • Diagnostic testCXCR4

    Participants diagnosed with PA will be asked to be scanned by 68Ga-PentixaFor PET imaging.

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What researchers measure

Primary outcomes

  1. renin

    measure the level of renin in blood

    Time frame: immediately after admission

  2. aldosterone

    measure the level of aldosterone in blood

    Time frame: immediately after admission

  3. SUVmax

    measure the maximum standardized uptake value of adrenal adenoma, liver, and lateral normal adrenal

    Time frame: immediately after 68Ga-PentixaFor PET imaging

  4. sensitivity

    the sensitivity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA

    Time frame: immediately after pathological examination

  5. specificity

    the specificity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA

    Time frame: immediately after pathological examination

  6. positive predictive value,PPV

    the PPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA

    Time frame: immediately after pathological examination

  7. negative predictive value, NPV

    the NPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA

    Time frame: immediately after pathological examination

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Study locations

1 of 1 sites recruiting
  • Zhongnan Hospital of Wuhan University
    Wuhan, Hubei 430071, China
    • Zhe Meng · Contact · +86 15387041020
    Recruiting
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References and documents

Publications

  • 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. PubMed 31849839 ↗
  • 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. PubMed 35998969 ↗
  • 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. PubMed 32206838 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05839483
Lead sponsor
Zhongnan Hospital
Responsible party
Sponsor
First posted
May 3, 2023
Start date
May 30, 2023
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jul 17, 2023

Study contacts

Zhe Meng
Contact
mengzhe@whu.edu.cn
+86 15387041020
Zhe Meng
principal investigator · Wuhan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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