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Trial Title:
[18F]AlF-NOTA-pentixather PET/CT in Patients With Suspected Primary Hyperaldosteronism
NCT ID:
NCT05815069
Condition:
Aldosterone-Producing Adenoma
Conditions: Official terms:
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:
[18F]AlF-NOTA-pentixather PET/CT
Description:
The radiotracer 18F-AlF-NOTA-pentixather PET/CT (dose 4.81 MBq/Kg body weight) was
injected intravenously according to the patient's body weight. The whole-body PET/CT
examination from the top of the skull to the root of the thigh was performed using a
PET/CT examination instrument (Siemens Biograph mCT Flow) 50-60 minutes after the
injection of radiopharmaceuticals. Flow Motion flow scanning technology with a matrix of
128x128 and a layer thickness of 3 mm was used. all PET images were iteratively
reconstructed. Patients who have undergone surgery routinely undergo pathological
examination.
Arm group label:
[18F]AlF-NOTA-pentixather
Other name:
pathological examination
Summary:
The study was proposed to include 20 patients with clinical suspicion of primary
aldosteronism for [18F]AlF-NOTA-pentixather PET/CT imaging and to analyze the specificity
and sensitivity of [18F]AlF-NOTA-pentixather PET/CT for the diagnosis of APA by
comparison with the final pathological findings.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Persistent hypertension or refractory hypertension (blood pressure >140/90 mmHg with
a combination of three antihypertensive drugs, including diuretics) with hypokalemia
of blood pressure >160/100 mmHg.
- Uncontrollable hypokalemia with or without hypertension. Persistent hypertension or
refractory hypertension with blood pressure >160/100 mmHg and aldosterone-renin
ratio (ARR) ≥30 (ng/dl)/(ng/ml/h).
- Positive captopril test (≤30% decrease in plasma aldosterone level after captopril
administration) is a sufficient but not mandatory condition.
- Patients with CT showing unilateral or bilateral adrenal nodules with well-defined
borders but normal serum potassium and ARR <30 (ng/dl)/(ng/ml/h) were also included
in the study.
Exclusion Criteria:
- Female patients who are pregnant (or intend to become pregnant within six months),
breastfeeding, or unwilling to use contraception.
- Abnormal cardiopulmonary function or mental status, unable to tolerate prone for 20
minutes.
- Refusal to sign an informed consent form or inability or unwillingness to comply
with the investigator-approved study protocol.
- Other conditions deemed by the investigator to be inappropriate for participation in
this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Sichuan Academy of Medical Sciences.Sichuan Provincial People's Hospital
Address:
City:
Chengdu
Zip:
610072
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Zhang, Ph.D
Phone:
86+02887393368
Email:
zhangwscd@uestc.edu.cn
Contact backup:
Last name:
Limeng He, MA.Sc
Email:
hlmxnykdx@163.com
Start date:
January 7, 2023
Completion date:
June 2024
Lead sponsor:
Agency:
Sichuan Provincial People's Hospital
Agency class:
Other
Source:
Sichuan Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05815069
