CXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis

NCT ID: NCT05839483

Last Updated: 2023-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-30

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aldosterone-Producing Adenoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CXCR4

scanned by 68Ga-PentixaFor PET imaging

Group Type EXPERIMENTAL

CXCR4

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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CXCR4

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhongnan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhe Meng

Role: PRINCIPAL_INVESTIGATOR

Wuhan University

Locations

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Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhe Meng

Role: CONTACT

+86 15387041020

Facility Contacts

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Zhe Meng

Role: primary

+86 15387041020

References

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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.

Reference Type RESULT
PMID: 31849839 (View on PubMed)

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.

Reference Type RESULT
PMID: 35998969 (View on PubMed)

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.

Reference Type RESULT
PMID: 32206838 (View on PubMed)

Other Identifiers

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Zhe Meng

Identifier Type: -

Identifier Source: org_study_id

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