Back to resultsCXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis
Primary Purpose
Aldosterone-Producing Adenoma
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CXCR4
Sponsored by
About this trial
This is an interventional diagnostic trial for Aldosterone-Producing Adenoma focused on measuring Hypertension, Hypokalemia, Adrenal adenoma
Eligibility Criteria
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.
Sites / Locations
- Zhongnan Hospital of Wuhan UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CXCR4
Arm Description
scanned by 68Ga-PentixaFor PET imaging
Outcomes
Primary Outcome Measures
renin
measure the level of renin in blood
aldosterone
measure the level of aldosterone in blood
SUVmax
measure the maximum standardized uptake value of adrenal adenoma, liver, and lateral normal adrenal
sensitivity
the sensitivity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA
specificity
the specificity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA
positive predictive value,PPV
the PPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA
negative predictive value, NPV
the NPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05839483
Brief Title
CXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis
Official Title
A Single Center Study on the Evaluation of Diagnostic Efficacy of CXCR4 Targeted PET Imaging in Primary Aldosteronism
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongnan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aldosterone-Producing Adenoma
Keywords
Hypertension, Hypokalemia, Adrenal adenoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CXCR4
Arm Type
Experimental
Arm Description
scanned by 68Ga-PentixaFor PET imaging
Intervention Type
Diagnostic Test
Intervention Name(s)
CXCR4
Intervention Description
Participants diagnosed with PA will be asked to be scanned by 68Ga-PentixaFor PET imaging.
Primary Outcome Measure Information:
Title
renin
Description
measure the level of renin in blood
Time Frame
immediately after admission
Title
aldosterone
Description
measure the level of aldosterone in blood
Time Frame
immediately after admission
Title
SUVmax
Description
measure the maximum standardized uptake value of adrenal adenoma, liver, and lateral normal adrenal
Time Frame
immediately after 68Ga-PentixaFor PET imaging
Title
sensitivity
Description
the sensitivity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA
Time Frame
immediately after pathological examination
Title
specificity
Description
the specificity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA
Time Frame
immediately after pathological examination
Title
positive predictive value,PPV
Description
the PPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA
Time Frame
immediately after pathological examination
Title
negative predictive value, NPV
Description
the NPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA
Time Frame
immediately after pathological examination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhe Meng
Phone
+86 15387041020
Email
mengzhe@whu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhe Meng
Organizational Affiliation
Wuhan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhe Meng
Phone
+86 15387041020
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31849839
Citation
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.
Results Reference
result
PubMed Identifier
35998969
Citation
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.
Results Reference
result
PubMed Identifier
32206838
Citation
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.
Results Reference
result
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CXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis
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