An observational study in Primary Aldosteronism, sponsored by Qifu Li. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-07-15.
Sponsored by Qifu Li · Observational
To evaluate the value of 68Ga-Pentixafor PET/CT in the diagnosis of primary aldosteronism subtype
This is a prospective study. We will enroll 100 patients with definite diagnosis of PA using adrenal venous sampling(AVS) as the gold standard for subtype to evaluate the value of 68Ga-pentixaforPET/CT in the diagnosis of PA.
201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.
This study's enrollment of 100 is below the median of 200 across 103 observational studies indexed under Hyperaldosteronism.
Browse Hyperaldosteronism studies →Qifu Li is the lead sponsor of 10 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Power Analysis and Sample Size software 11 (PASS 11) was used to calculate the sample size. A sample of 40 from the positive group (i.e. UPA group) and 60 from the negative group (i.e. BPA group) achieves 84% power to detect a difference of 0·15 between the area under the receiver-operator characteristics curve (AUC) under the null hypothesis of 0·70 and an AUC under the alternative hypothesis of 0·85 using a two-sided z-test at a significance level of 0·05.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PA confirmatory tests was positive; successful intubation (SI ≥ 3) and LI ≥ 4; If LI between 2 and 4, should be combined with contralateral inhibition index \< 1 or CT indicate typical adenomas on the dominant side.
Diagnostic Test: 68Ga-Pentixafor PET/CT imaging
PA confirmatory tests was positive; successful intubation (SI ≥ 3) and LI \< 2; or LI between 2 and 4 but does not meet the UPA conditions
Diagnostic Test: 68Ga-Pentixafor PET/CT imaging
68Ga-Pentixafor PET/CT imaging
accuracy of 68Ga-PentixaforPET/CT in subtyping diagnosis of PA
AUC
Time frame: at the end of study(the last enrolled patient completed a 3-month follow-up)
Plan to share: No
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Qifu Li