Application of 68Ga-Pentixafor PET/CT in Primary Aldosteronism and Pre-postoperative of SAAE

Sponsor
First Affiliated Hospital of Fujian Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05188872
Collaborator
(none)
100
1
1
36
2.8

Study Details

Study Description

Brief Summary

Primary aldosteronism is the most common cause of secondary hypertension. The two main types of primary aldosteronism are aldosteronoma(30%) and adrenal hyperplasia(60%). The gold standard that determines the diagnosis and treatment strategy of primary aldosteronism is adrenal vein sampling(AVS), but the success rate is only about 80%. Using CXCR4 as a probe for 68Ga-Pentixafor PET/CT imaging can guide the classification diagnosis and treatment strategy of primary aldosteronism, which is a favorable supplement to AVS. Superselective adrenal artery embolization(SAAE) and laparoscopy are the main operation treatments for primary aldosteronism. SAAE is an invasive interventional operation. It is a novel way to evaluate the changes in the structure and function of adrenal tissue pre-postoperative SAAE by using the changes in 68Ga-Pentixafor PET/CT imaging.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 68Ga-Pentixafor
N/A

Detailed Description

Primary aldosteronism: Hypertension is divided into primary hypertension and secondary hypertension. Secondary hypertension refers to hypertension with clear etiology. When the etiology is identified and effectively removed or controlled, hypertension as a secondary symptom can be cured or significantly relieved. The most common secondary hypertension is primary aldosteronism. Primary aldosteronism is due to excessive aldosterone secretion in the adrenal cortex, characterized by clinical syndromes of hyperaldosteronism, low renin activity, hypertension and hypokalemia. Compared with essential hypertension, the risk of cardiovascular and cerebrovascular events and the risk of target organ damage in patients with primary aldosteronism were significantly increased. On the contrary, early detection and treatment mean better blood pressure control, lighter target organ damage and better clinical outcomes. The two main types of primary aldosteronism are aldosteronoma(30%) and adrenal hyperplasia(60%). The gold standard that determines the diagnosis and treatment strategy of primary aldosteronism is adrenal vein sampling (AVS), but the success rate is only about 80 %. Therefore, it is necessary to explore a non-invasive examination method as a beneficial supplement to AVS.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
68Ga-Pentixafor PET/CT in the Diagnosis of Primary Aldosteronism and Pre-postoperative of Superselective Adrenal Artery Embolization
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 68Ga-Pentixafor

Each subject receive a single intravenous injection of 68Ga-Pentixafor, and undergo PET/CT imaging within the specificed time

Diagnostic Test: 68Ga-Pentixafor
Each patient receive a single intravenous injection of 68Ga-Pentixafor, and undergo PET/CT scan within specified time.
Other Names:
  • PET/CT scan
  • Outcome Measures

    Primary Outcome Measures

    1. Standardized uptake value (SUV) [through study completion,an average of 3 years]

      Standardized uptake value (SUV) of 68Ga-Pentixafor for each target or suspected lesion of subject.

    Secondary Outcome Measures

    1. SAAE treatment evaluation [through study completion,an average of 3 years]

      68Ga-Pentixafor PET/CT imaging to evaluate the changes in the structure and function of adrenal tissue pre-postoperative SAAE.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • adult population (aged 18 years or order);

    • patients with suspected or new diagnosed Primary aldosteronism (supporting evidence may include MRI, CT, laboratory tests);

    • patients who had scheduled 68Ga-BNU-PSMA PET/CT scan;

    • patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee;

    • healthy volunteers(aged 18 years or order).

    Exclusion Criteria:
    • patients with pregnancy;

    • the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University Fuzhou Fujian China 350005

    Sponsors and Collaborators

    • First Affiliated Hospital of Fujian Medical University

    Investigators

    • Study Chair: Liangdi Xie, MD, the First Affiliated Hospital, Fujian Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Weibing Miao, PhD, Director, Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
    ClinicalTrials.gov Identifier:
    NCT05188872
    Other Study ID Numbers:
    • FirstAHFujian12
    First Posted:
    Jan 12, 2022
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 28, 2022