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

Official title

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

Overview

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.

Interventions

• Diagnostic test 68Ga-Pentixafor PET/CT
  The patients had a normal diet with no special preparation before 68Ga-Pentixafor PET/CT imaging. The dosage of intravenously injected 68Ga-Pentixafor was calculated based on the patient's weight (1.85 MBq \[0.05mCi\]/kg). Local PET/CT scanning of the upper abdomen was performed on a hybrid PET/CT scanner at 10 minutes after the injection of the intravenous tracer, respectively.

Primary outcome measures

• The proportion of complete biochemical remission [Time frame: At 6 months of follow-up.]

Secondary outcome measures (7)

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Diagnostic

Study locations

China · 1 center

• The First Affilated Hospital of Chongqing Medical University — Chongqing

Publications

• Rossi GP, Bernini G, Caliumi C, Desideri G, Fabris B, Ferri C, Ganzaroli C, Giacchetti G, Letizia C, Maccario M, Mallamaci F, Mannelli M, Mattarello MJ, Moretti A, Palumbo G, Parenti G, Porteri E, Semplicini A, Rizzoni D, Rossi E, Boscaro M, Pessina AC, Mantero F; PAPY Study Investigators. A prospective study of the prevalence of primary aldosteronism in 1,125 hypertensive patients. J Am Coll Card PMID 17161262
• Xu Z, Yang J, Hu J, Song Y, He W, Luo T, Cheng Q, Ma L, Luo R, Fuller PJ, Cai J, Li Q, Yang S; Chongqing Primary Aldosteronism Study (CONPASS) Group. Primary Aldosteronism in Patients in China With Recently Detected Hypertension. J Am Coll Cardiol. 2020 Apr 28;75(16):1913-1922. doi: 10.1016/j.jacc.2020.02.052. PMID 32327102
• Mulatero P, Sechi LA, Williams TA, Lenders JWM, Reincke M, Satoh F, Januszewicz A, Naruse M, Doumas M, Veglio F, Wu VC, Widimsky J. Subtype diagnosis, treatment, complications and outcomes of primary aldosteronism and future direction of research: a position statement and consensus of the Working Group on Endocrine Hypertension of the European Society of Hypertension. J Hypertens. 2020 Oct;38(10): PMID 32890265
• Monticone S, D'Ascenzo F, Moretti C, Williams TA, Veglio F, Gaita F, Mulatero P. Cardiovascular events and target organ damage in primary aldosteronism compared with essential hypertension: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2018 Jan;6(1):41-50. doi: 10.1016/S2213-8587(17)30319-4. Epub 2017 Nov 9. PMID 29129575
• Hundemer GL, Curhan GC, Yozamp N, Wang M, Vaidya A. Renal Outcomes in Medically and Surgically Treated Primary Aldosteronism. Hypertension. 2018 Sep;72(3):658-666. doi: 10.1161/HYPERTENSIONAHA.118.11568. PMID 29987110
• Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2. PMID 26934393
• Amar L, Baguet JP, Bardet S, Chaffanjon P, Chamontin B, Douillard C, Durieux P, Girerd X, Gosse P, Hernigou A, Herpin D, Houillier P, Jeunemaitre X, Joffre F, Kraimps JL, Lefebvre H, Menegaux F, Mounier-Vehier C, Nussberger J, Pagny JY, Pechere A, Plouin PF, Reznik Y, Steichen O, Tabarin A, Zennaro MC, Zinzindohoue F, Chabre O. SFE/SFHTA/AFCE primary aldosteronism consensus: Introduction and handb PMID 27315757
• Nishikawa T, Omura M, Satoh F, Shibata H, Takahashi K, Tamura N, Tanabe A; Task Force Committee on Primary Aldosteronism, The Japan Endocrine Society. Guidelines for the diagnosis and treatment of primary aldosteronism--the Japan Endocrine Society 2009. Endocr J. 2011;58(9):711-21. doi: 10.1507/endocrj.ej11-0133. Epub 2011 Aug 9. PMID 21828936

Identifiers

NCT: NCT06238232 · GAPA study

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗