Evaluating a PET/CT scan for diagnosing a specific type of adrenal gland disorder
Accuracy of 68Ga-Pentixafor PET/CT for Subtypting Diagnosis in Patients With Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion
This study is testing if a special type of PET/CT scan can help diagnose a specific adrenal gland disorder in patients who have adrenal nodules and are considering surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 97 (estimated) |
| Sex | All |
| Sponsor | Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT06635993 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the accuracy of 68Ga-Pentixafor PET/CT imaging in diagnosing primary aldosteronism concurrent with autonomous cortisol secretion in patients with adrenal nodules. It involves a multicenter, prospective design where 97 patients will undergo both adrenal venous sampling (AVS) and PET/CT scans. The results from these imaging techniques will be compared against AVS and postoperative remission to determine diagnostic accuracy. The study focuses on patients who are willing to undergo surgery and have specific hormonal profiles.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with primary aldosteronism and concurrent autonomous cortisol secretion who have adrenal nodules of 1 cm or larger.
Not a fit: Patients with conditions such as familial hyperaldosteronism, pheochromocytoma, or those who have had prior adrenal surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the diagnostic accuracy for patients with complex adrenal disorders, leading to better-targeted treatments.
How similar studies have performed: While the use of PET/CT in adrenal disorders is emerging, this specific application for concurrent primary aldosteronism and cortisol secretion is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Getting the written informed consent 2. The clear diagnosis of primary aldosteronism； 3. Combined with autonomous cortisol secretion, cortisol after 1mg dexamethasone suppression test (DST) ≥50 nmol/l； 4. Patients who are willing to undergo surgery； 5. Adrenal CT or MRI scan of the adrenal glands with nodule (≥1cm). Exclusion Criteria: 1. PA patients who meet the by-passing AVS criteria \[i.e., younger than 35 years old, spontaneous hypokalemia, adrenal CT indicated unilateral low-density adenoma (≥1cm), plasma aldosterone \&gt;300pg/ml\]； 2. Suspicion of familial hyperaldosteronism or Liddle syndrome. \[i.e., age \&lt;20 years, hypertension and hypokalemia, or with family history\]； 3. Suspicion of pheochromocytoma or adrenal carcinoma； 4. Patients with actively malignant tumor； 5. Patients who have adrenalectomy history； 6. Long-term use of glucocorticoids； 7. Patients who are allergic to contrast media and cannot tolerate AVS； 8. Pregnant or lactating women; with alcohol or drug abuse and mental disorders； 9. 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); Untreated aneurysm; Other comorbidity potentially interfering with treatment； 10. Consider patients with bilateral cortisol hypersecretion such as PBMAH or PPNAD.
Where this trial is running
Chongqing, Chongqing Municipality
- The First Affilated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Qi fu Li, PhD
- Email: liqifu@yeah.net
- Phone: 86-89011552
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.