Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06238232

Outcome of 68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Primary Aldosteronism

Led by Qifu Li · Updated on 2024-04-30

320

Participants Needed

1

Research Sites

207 weeks

Total Duration

On this page

Sponsors

Q

Qifu Li

Lead Sponsor

T

The Affiliated Hospital Of Southwest Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

To compare the 68Ga-Pentixafor PET/CT and adrenal vein sampling on the long-term outcomes of primary aldosteronism (PA) patients with adrenal nodule (≥1cm)

CONDITIONS

Official Title

Outcome of 68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Primary Aldosteronism

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent
  • Have an aldosterone-renin ratio (ARR) ≥ 20 (pg/ml)/(µIU/ml) or ARR ≥ 30 (ng/dL)/(ng/ml/hr) plus at least one positive confirmatory test for primary aldosteronism
  • Be willing to undergo surgery
  • Have hypertension and be aged between 18 and 70 years
  • Have an adrenal gland nodule measuring 1 cm or larger on CT or MRI scan
Not Eligible

You will not qualify if you...

  • Have autonomous cortisol secretion with cortisol after 1 mg dexamethasone suppression test ≥ 50 nmol/l
  • Meet bypass adrenal vein sampling criteria: younger than 35 years, spontaneous low potassium, unilateral adrenal low-density adenoma ≥ 1 cm, or plasma aldosterone > 300 pg/ml
  • Suspected familial hyperaldosteronism or Liddle syndrome (age < 20 years, hypertension and low potassium, or family history)
  • Suspected pheochromocytoma or adrenal carcinoma
  • Have an active malignant tumor
  • Have a history of adrenalectomy or adrenal insufficiency
  • Use long-term glucocorticoids
  • Are pregnant or lactating, or have alcohol/drug abuse or mental disorders
  • Have congestive heart failure NYHA class III or IV
  • Have serious cardiovascular or cerebrovascular disease in past 3 months
  • Have severe anemia (hemoglobin < 60 g/L)
  • Have serious liver dysfunction or chronic kidney disease (AST or ALT > 3 times upper limit, or eGFR < 30 ml/min/1.73 m2)
  • Have systemic inflammatory response syndrome (SIRS)
  • Have uncontrolled diabetes (fasting blood glucose ≥ 13.3 mmol/L)
  • Are obese (BMI ≥ 35 kg/m²) or underweight (BMI ≤ 18 kg/m²)
  • Have untreated aneurysm
  • Have other comorbidities that might interfere with treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affilated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 400016

Actively Recruiting

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Research Team

Q

Qifu Li, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Outcome of 68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Primary Aldosteronism | DecenTrialz