Autonomous Cortisol Secretion, Primary Aldosteronism
Conditions
Keywords
Primary aldosteronism, Autonomous cortisol secretion, Adrenal venous sampling, 68Ga-Pentixafor PET/CT, outcome, multicenter randomized crossover trial
Brief summary
To validate the accuracy of 68Ga-Pentixafor PET/CT and adrenal venous sampling (AVS) in subtype diagnosis of PA/ACS patients with adrenal nodules, based on biochemical and clinical remission outcomes, and to determine whether the diagnostic accuracy of 68Ga-Pentixafor PET/CT is non-inferior to AVS.
Detailed description
This is a prospective, multicenter, randomized crossover trial. Patients with a confirmed diagnosis of primary aldosteronism (PA) or autonomous cortisol secretion (ACS) with adrenal nodules were prospectively enrolled. They were randomized to undergo 68Ga-Pentixafor PET/CT and adrenal venous sampling (AVS) in a crossover design for subtype diagnosis. The treatment strategy was determined based on the diagnostic results, with the primary endpoint being the biochemical complete remission rate at 6 months postoperatively. The study aims to compare the value of these two methods in the subtype diagnosis of PA.
Interventions
DIAGNOSTIC_TEST68Ga-Pentixafor PET/CT
Patients in the 68Ga-Pentixafor PET/CT group will first undergo 68Ga-Pentixafor PET/CT, followed by adrenal venous sampling (AVS). The subsequent treatment will be guided based on the diagnostic results. The diagnosis of unilateral PA was made if LISUVmax ≥1.50 or or unilateral functional adrenal tumor based on 68Ga-Pentixafor PET/CT
DIAGNOSTIC_TESTAVS
Patients in the adrenal venous sampling (AVS) group will first undergo adrenal venous sampling (AVS), followed by 68Ga-Pentixafor PET/CT. The subsequent treatment will be guided based on the diagnostic results. The diagnosis of unilateral PA was made LI ≥ 4 or LI 2-4 with contralateral suppression or typical nodule on the dominant side by CT
Sponsors
Qifu Li
The Affiliated Hospital Of Southwest Medical University
Changzhi Medical College
First Affiliated Hospital of Kunming Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Getting the written informed consent; * PA conccurent with autonomous cortisol secretion; * Patients with hypertension aged 18-70 years; * CT or MRI scan of the adrenal glands with adenoma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of complete biochemical remission | At 6 months of follow-up | Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of complete clinical remission | At 6 months of follow-up | Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria. |
| In surgical population, the proportion of complete biochemical remission | At 6 months of follow-up | Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria. |
| In surgical population, the proportion of complete clinical remission | At 6 months of follow-up | Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria. |
| In surgical population, the accuracy in identifying unilateral primary aldosteronism. | At 6 months of follow-up | Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.the accuracy in identifying unilateral primary according to PASO consensus criteria. |
| In the surgical treatment group, the remission rate of cortisol autonomous secretion | at the 6-month follow-up assessment | Blood was drawn to measure cortisol.The remission of cortisol autonomous secretion is defined as cortisol after 1mg dexamethasone suppression test \<1.8 μg/dL. |
Countries
China
Contacts
CONTACTQifu Li
STUDY_CHAIRQifu Li
the Chongqing Primary Aldosteronism Study (CONPASS) Group
Outcome results
None listed