BridgeMD
Compares treatment options for Primary Aldosteronism
Official title 68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Diagnosing Unilateral Subtype of Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion (PREDICT)
ClinicalTrials.gov ID: NCT06833437
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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.
You likely can't join if
- Exclusion Criteria:
- Unable to complete 68Ga-Pentixafor PET/CT or AVS;
- Refusal of surgery or contraindications for surgery;
- PA patients who meet the by-passing AVS criteria [i.e., younger than 35 years old, spontaneous hypokalemia, adrenal CT indicated unilateral...
- Suspicion of familial hyperaldosteronism or Liddle syndrome. [i.e., age \<20 years, hypertension and hypokalemia, or with family history];
- Suspicion of pheochromocytoma or adrenal carcinoma;
See the full eligibility 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.
- Exclusion Criteria:
- Unable to complete 68Ga-Pentixafor PET/CT or AVS;
- Refusal of surgery or contraindications for surgery;
- PA patients who meet the by-passing AVS criteria [i.e., younger than 35 years old, spontaneous hypokalemia, adrenal CT indicated unilateral low-density adenoma (≥1cm), plasma aldosterone \>300pg/ml]
- Suspicion of familial hyperaldosteronism or Liddle syndrome. [i.e., age \<20 years, hypertension and hypokalemia, or with family history];
- Suspicion of pheochromocytoma or adrenal carcinoma;
- Patients with actively malignant tumor;
- Patients who have adrenalectomy history;
- Long-term use of glucocorticoids;
- Pregnant or lactating women; with alcohol or drug abuse and mental disorders;
- Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV; History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 3...
- Suspected PBMAH or PPNAD;
- Poor compliance or any other reason deemed unsuitable for inclusion by the investigators;
- Patients with adrenal insufficiency requiring hormone replacement therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.