Application of 68Ga-Pentixafor PET/CT in Primary Aldosteronism and Pre-postoperative of SAAE
Primary Purpose
Positron-Emission Tomography
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
68Ga-Pentixafor
Sponsored by
About this trial
This is an interventional diagnostic trial for Positron-Emission Tomography
Eligibility Criteria
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.
Sites / Locations
- Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-Pentixafor
Arm Description
Each subject receive a single intravenous injection of 68Ga-Pentixafor, and undergo PET/CT imaging within the specificed time
Outcomes
Primary Outcome Measures
Standardized uptake value (SUV)
Standardized uptake value (SUV) of 68Ga-Pentixafor for each target or suspected lesion of subject.
Secondary Outcome Measures
SAAE treatment evaluation
68Ga-Pentixafor PET/CT imaging to evaluate the changes in the structure and function of adrenal tissue pre-postoperative SAAE.
Full Information
NCT ID
NCT05188872
First Posted
August 30, 2021
Last Updated
September 15, 2023
Sponsor
First Affiliated Hospital of Fujian Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05188872
Brief Title
Application of 68Ga-Pentixafor PET/CT in Primary Aldosteronism and Pre-postoperative of SAAE
Official Title
68Ga-Pentixafor PET/CT in the Diagnosis of Primary Aldosteronism and Pre-postoperative of Superselective Adrenal Artery Embolization
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Fujian Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Positron-Emission Tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-Pentixafor
Arm Type
Experimental
Arm Description
Each subject receive a single intravenous injection of 68Ga-Pentixafor, and undergo PET/CT imaging within the specificed time
Intervention Type
Diagnostic Test
Intervention Name(s)
68Ga-Pentixafor
Other Intervention Name(s)
PET/CT scan
Intervention Description
Each patient receive a single intravenous injection of 68Ga-Pentixafor, and undergo PET/CT scan within specified time.
Primary Outcome Measure Information:
Title
Standardized uptake value (SUV)
Description
Standardized uptake value (SUV) of 68Ga-Pentixafor for each target or suspected lesion of subject.
Time Frame
through study completion,an average of 3 years
Secondary Outcome Measure Information:
Title
SAAE treatment evaluation
Description
68Ga-Pentixafor PET/CT imaging to evaluate the changes in the structure and function of adrenal tissue pre-postoperative SAAE.
Time Frame
through study completion,an average of 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weibing Miao, MD
Phone
86-0591-87981618
Email
miaoweibing@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jinxiu Lin, MD
Phone
86-13799777113
Email
linjinxiu@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liangdi Xie, MD
Organizational Affiliation
the First Affiliated Hospital, Fujian Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weibing Miao, MD
Phone
059187981618
Email
miaoweibing@126.com
First Name & Middle Initial & Last Name & Degree
Jinxiu Lin, MD
Phone
86-13799977713
Email
linjinxiu@aliyun.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Application of 68Ga-Pentixafor PET/CT in Primary Aldosteronism and Pre-postoperative of SAAE
We'll reach out to this number within 24 hrs