Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06833437

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

Led by Qifu Li · Updated on 2026-02-05

178

Participants Needed

1

Research Sites

282 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 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided written informed consent
  • Diagnosed with primary aldosteronism concurrent with autonomous cortisol secretion
  • Patients with hypertension aged 18 to 70 years
  • Adrenal adenoma confirmed by CT or MRI scan
Not Eligible

You will not qualify if you...

  • Unable to complete 68Ga-Pentixafor PET/CT or adrenal venous sampling (AVS)
  • Refusal of surgery or contraindications to surgery
  • Primary aldosteronism patients meeting bypass AVS criteria: younger than 35 years, spontaneous hypokalemia, unilateral low-density adenoma ≥1 cm on CT, plasma aldosterone >300 pg/ml
  • Suspicion of familial hyperaldosteronism or Liddle syndrome (age <20 years, hypertension and hypokalemia, or family history)
  • Suspicion of pheochromocytoma or adrenal carcinoma
  • Active malignant tumor
  • History of adrenalectomy
  • Long-term glucocorticoid use
  • Pregnant or lactating women; alcohol or drug abuse; mental disorders
  • Congestive heart failure NYHA class III or IV; recent serious cardiovascular or cerebrovascular disease
  • Severe anemia (Hb <60 g/L)
  • Serious liver dysfunction or chronic kidney disease (AST or ALT >3 times normal, 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 comorbidities that may interfere with treatment
  • Suspected primary bilateral macronodular adrenal hyperplasia (PBMAH) or primary pigmented nodular adrenocortical disease (PPNAD)
  • Poor compliance or other investigator-determined unsuitability
  • Adrenal insufficiency requiring hormone replacement therapy

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

The First Affilated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Actively Recruiting

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Research Team

Q

Qifu Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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