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Clinical Trials/NCT06238232
NCT06238232RecruitingNot Applicable

68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling to Determine Treatment in Primary Aldosteronism: A Multicenter Randomized Clinical Trial

Qifu Li1 site in 1 country320 target enrollmentStarted: January 9, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
320
Locations
1
Primary Endpoint
The proportion of complete biochemical remission
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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)

Detailed Description

This is a randomized study involving patients with primary aldosteronism (PA) patients with adrenal nodule (≥1cm) who completed AVS or 68Ga-Pentixafor PET/CT.We will enroll 320 PA patients with adrenal nodule (≥1cm) .All paticipants will be randomized into 68Ga-Pentixafor PET/CT group(Intervention group) and AVS group(Control group) to compare the long-term outcomes of patients with PA.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •(1)Getting the written informed consent (2)ARR ≥20 (pg/ml)/ (μIU/ml) or ARR ≥ 30(ng/dL)/(ng/ml/hr) plus at least one positive PA confirmatory test (CCT, SSIT).
  • •(3)Patients who are willing to undergo surgery. (4)Patients with hypertension aged 18-70 years. (5)CT or MRI scan of the adrenal glands with nodule (≥1cm).

Exclusion Criteria

  • •Combined with autonomous cortisol secretion, cortisol after 1mg dexamethasone suppression test (DST) ≥50 nmol/l.
  • •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 or with adrenocortical insufficiency.
  • •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

Outcomes

Primary Outcomes

The proportion of complete biochemical remission

Time Frame: At 6 months of follow-up.

Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria.

Secondary Outcomes

  • In surgical population, the proportion of complete biochemical remission(At 6 months of follow-up.)
  • In surgical population, the proportion of complete clinical remission(At 6 months of follow-up.)
  • Total cost of diagnosis and treatment(At baseline and 6 months of follow-up.)
  • Comparison of adverse events(At baseline and 6 month of follow-up.)
  • Daily defined doses (DDD) of antihypertensive agents(At 6-12 months of follow-up.)
  • Health Related Quality of Life(At baseline and 6 months of follow-up.)
  • The proportion of complete clinical remission(At 6 months of follow-up.)

Investigators

Sponsor
Qifu Li
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Qifu Li

Primary investigator

Chongqing Medical University

Study Sites (1)

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