Accuracy of 68Ga-Pentixafor PET/CT for Subtypting Diagnosis in Patients With Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion

Last updated: October 9, 2024
Sponsor: Qifu Li
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

68Ga-Pentixafor PET/CT

Clinical Study ID

NCT06635993
ABOARD study
  • All Genders

Study Summary

To evaluate the accuracy of 68Ga-Pentixafor PET-CT in the classification diagnosis of primary aldosteronism concurrent with autonomous cortisol secretion patient, using AVS and/or postoperative remission as the reference standard for classification diagnosis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Getting the written informed consent

  2. The clear diagnosis of primary aldosteronism;

  3. Combined with autonomous cortisol secretion, cortisol after 1mg dexamethasonesuppression 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

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 >300pg/ml];

  2. Suspicion of familial hyperaldosteronism or Liddle syndrome. [i.e., age <20years, 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) FunctionalClassification III or IV; History of serious cardiovascular or cerebrovasculardisease (angina, myocardial infarction or stroke) in the past 3 months; Severeanemia (Hb<60g/L); Serious liver dysfunction or chronic kidney disease aspartateaminotransferase (AST) or alanine transaminase (ALT) ≥3 times the upper limit ofnormal, or estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m2);Systemic Inflammatory Response Syndrome (SIRS); Uncontrolled diabetes (FBG≥13.3mmol/L); Obesity (BMI≥35 kg/m²); Untreated aneurysm; Other comorbidity potentiallyinterfering with treatment;

  10. Consider patients with bilateral cortisol hypersecretion such as PBMAH or PPNAD.

Study Design

Total Participants: 97
Treatment Group(s): 1
Primary Treatment: 68Ga-Pentixafor PET/CT
Phase:
Study Start date:
August 12, 2024
Estimated Completion Date:
August 12, 2027

Study Description

This study is a multicenter, prospective, diagnostic trial involving patients with primary aldosteronism (PA) concurrent with autonomous cortisol secretion (ACS) patients with adrenal nodule (≥1cm) who completed both AVS and 68Ga-Pentixafor PET/CT. We will enroll 97 PA concurrent with ACS patients with adrenal nodule (≥1cm) .The treatment plan was determined according to the AVS results. AVS and/or postoperative remission were used as the reference standard for classification diagnosis to evaluate the accuracy of 68Ga-Pentixafor PET-CT in the classification diagnosis of PA concurrent with ACS patients.

Connect with a study center

  • The First Affilated Hospital of Chongqing Medical University

    Chongqing, Chongqing 400016
    China

    Active - Recruiting

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