CXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis

NCT05839483 | Unknown DMC

• 1 other identifier: Zhe Meng
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Aldosterone-Producing Adenoma

Keywords

Hypertension; Hypokalemia; Adrenal adenoma

Outcome Measures

Primary Outcomes (7)

• renin

  measure the level of renin in blood

  immediately after admission

• aldosterone

  measure the level of aldosterone in blood

  immediately after admission

• SUVmax

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

  immediately after 68Ga-PentixaFor PET imaging

• sensitivity

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

  immediately after pathological examination

• specificity

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

  immediately after pathological examination

• positive predictive value,PPV

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

  immediately after pathological examination

• negative predictive value, NPV

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

  immediately after pathological examination

Study Arms (1)

CXCR4

EXPERIMENTAL

scanned by 68Ga-PentixaFor PET imaging

Diagnostic Test: CXCR4

Interventions

CXCR4 DIAGNOSTIC_TEST

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

CXCR4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 31849839 RESULT

• 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.

  PMID: 35998969 RESULT

• 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.

  PMID: 32206838 RESULT

MeSH Terms

Conditions

Adrenocortical Adenoma; Hypertension; Hypokalemia; ACTH Syndrome, Ectopic

Condition Hierarchy (Ancestors)

Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Adrenal Cortex Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Paraneoplastic Endocrine Syndromes; Paraneoplastic Syndromes

Study Officials

• Zhe Meng

  Wuhan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhe Meng

CONTACT

+86 15387041020; mengzhe@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: May 3, 2023
• Study Start: May 30, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: July 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)