To hear about similar clinical trials, please enter your email below
Trial Title:
CXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis
NCT ID:
NCT05839483
Condition:
Aldosterone-Producing Adenoma
Conditions: Official terms:
Adenoma
Conditions: Keywords:
Hypertension
Hypokalemia
Adrenal adenoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
CXCR4
Description:
Participants diagnosed with PA will be asked to be scanned by 68Ga-PentixaFor PET
imaging.
Arm group label:
CXCR4
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430071
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhe Meng
Phone:
+86 15387041020
Start date:
May 30, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Zhongnan Hospital
Agency class:
Other
Source:
Zhongnan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05839483
