68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Diagnosing Unilateral Subtype of Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion (PREDICT)

Launched by QIFU LI · Feb 13, 2025

Keywords

ClinConnect Summary

This clinical trial, called PREDICT, is studying two different methods for diagnosing a condition known as Primary Aldosteronism (PA) that occurs together with Autonomous Cortisol Secretion (ACS). The trial is comparing the use of a special imaging test called 68Ga-Pentixafor PET/CT to a procedure known as adrenal vein sampling (AVS) to see which method is more accurate in finding the specific type of PA/ACS that patients may have. The goal is to ensure that the new imaging test is just as reliable as the traditional method, while also looking at how patients respond to treatment afterward.

To participate in this trial, you need to be between 18 and 70 years old, have high blood pressure, and have been diagnosed with PA and ACS, confirmed by a CT or MRI scan showing an adrenal adenoma (a type of tumor on the adrenal gland). The trial is currently looking for participants, and those who join can expect to undergo both diagnostic tests. It's important to note that certain health conditions, such as serious heart problems or a history of certain cancers, may prevent someone from participating. This study could help improve how doctors diagnose and treat conditions related to adrenal gland issues in the future.

Gender

ALL

Eligibility criteria

• 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. Exclusion criteria
• 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 months; Severe anemia (Hb\<60g/L); Serious liver dysfunction or chronic kidney disease aspartate aminotransferase (AST) or alanine transaminase (ALT) \>3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2); Systemic Inflammatory Response Syndrome (SIRS); Uncontrolled diabetes (FBG≥13.3 mmol/L); Obesity (BMI≥35 kg/m²) or Underweight (BMI≤18 kg/m²); Untreated aneurysm; Other comorbidity potentially interfering with treatment;
• • 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.