68Ga-Pentixafor PET/CT for the Subtyping Diagnosis of Primary Aldosteronism

68Ga-Pentixafor PET/CT for the Subtyping Diagnosis of Primary Aldosteronism: A Prospective Diagnostic Accuracy Study

To evaluate the value of 68Ga-Pentixafor PET/CT in the diagnosis of primary aldosteronism subtype

Study Overview

• Status: Completed
• Conditions: Primary Aldosteronism
• Intervention / Treatment: Diagnostic test: 68Ga-Pentixafor PET/CT imaging

Detailed Description

This is a prospective study. We will enroll 100 patients with definite diagnosis of PA using adrenal venous sampling(AVS) as the gold standard for subtype to evaluate the value of 68Ga-pentixaforPET/CT in the diagnosis of PA.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • The First Affilated Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Power Analysis and Sample Size software 11 (PASS 11) was used to calculate the sample size. A sample of 40 from the positive group (i.e. UPA group) and 60 from the negative group (i.e. BPA group) achieves 84% power to detect a difference of 0·15 between the area under the receiver-operator characteristics curve (AUC) under the null hypothesis of 0·70 and an AUC under the alternative hypothesis of 0·85 using a two-sided z-test at a significance level of 0·05.

Description

Inclusion Criteria:

1. PA diagnosis confirmed by at least one confirmatory test
2. willingness to undergo AVS and surgery
3. informed consent to participate in the study.

Exclusion Criteria:

1. PA patients who met guideline criteria for bypassing AVS [i.e. younger than 35 years old, with typical APA characteristics (plasma aldosterone >300pg/ml, plasma renin < 2·5mIU/l, serum potassium <3·5mmol/l, CT indicated unilateral 1cm low-density adenoma);
2. failed adrenal vein cannulation during AVS;
3. Subtyping diagnosis was inconclusive based on AVS results (e.g. aldosterone/cortisol ratio in bilateral adrenal veins lower than the peripheral vein, or missing data);
4. pregnant or lactating women;
5. patients with a history of uncontrolled malignant tumor;
6. concurrent Cushing's syndrome [including mild autonomous cortisol secretion: cortisol after 1mg dexamethasone suppression test (DST)>138 nmol/l or cortisol after 2mg DST >50 nmol/l or cortisol after 1mg DST 50-138 nmol/l plus adrenocorticotrophic hormone (ACTH)<10pg/ml;
7. diagnosis of familial hyperaldosteronism;
8. imaging characteristics suggestive of pheochromocytoma or adrenal cortical carcinoma;
9. unsuitable for surgery, such as heart failure with New York Heart Association (NYHA) class III or IV, severe anemia (Hemoglobin<60g/L), stroke or acute coronary syndrome within 3 months, severe ascites and cirrhosis, estimated glomerulus filtration rate<30ml/min/m;
10. alcohol or drug abuse and mental disorders.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
unilateral primary aldosteronism(UPA); PA confirmatory tests was positive; successful intubation (SI ≥ 3) and LI ≥ 4; If LI between 2 and 4, should be combined with contralateral inhibition index < 1 or CT indicate typical adenomas on the dominant side.	Diagnostic test: 68Ga-Pentixafor PET/CT imaging; 68Ga-Pentixafor PET/CT imaging
bilateral adrenal hyperplasia(BAH); PA confirmatory tests was positive; successful intubation (SI ≥ 3) and LI < 2; or LI between 2 and 4 but does not meet the UPA conditions	Diagnostic test: 68Ga-Pentixafor PET/CT imaging; 68Ga-Pentixafor PET/CT imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
accuracy of 68Ga-PentixaforPET/CT in subtyping diagnosis of PA	AUC	at the end of study(the last enrolled patient completed a 3-month follow-up)

Collaborators and Investigators

• Sponsor: Qifu Li
• Collaborators: The Affiliated Hospital Of Southwest Medical University

Publications and helpful links

General Publications

• 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.
• Monticone S, Burrello J, Tizzani D, Bertello C, Viola A, Buffolo F, Gabetti L, Mengozzi G, Williams TA, Rabbia F, Veglio F, Mulatero P. Prevalence and Clinical Manifestations of Primary Aldosteronism Encountered in Primary Care Practice. J Am Coll Cardiol. 2017 Apr 11;69(14):1811-1820. doi: 10.1016/j.jacc.2017.01.052.
• 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 Cardiol. 2006 Dec 5;48(11):2293-300. doi: 10.1016/j.jacc.2006.07.059. Epub 2006 Nov 13.
• Young WF, Stanson AW, Thompson GB, Grant CS, Farley DR, van Heerden JA. Role for adrenal venous sampling in primary aldosteronism. Surgery. 2004 Dec;136(6):1227-35. doi: 10.1016/j.surg.2004.06.051.
• 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.
• 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):1929-1936. doi: 10.1097/HJH.0000000000002520.
• Rossi GP, Rossitto G, Amar L, Azizi M, Riester A, Reincke M, Degenhart C, Widimsky J Jr, Naruse M, Deinum J, Schultze Kool L, Kocjan T, Negro A, Rossi E, Kline G, Tanabe A, Satoh F, Christian Rump L, Vonend O, Willenberg HS, Fuller PJ, Yang J, Chee NYN, Magill SB, Shafigullina Z, Quinkler M, Oliveras A, Dun Wu K, Wu VC, Kratka Z, Barbiero G, Battistel M, Chang CC, Vanderriele PE, Pessina AC. Clinical Outcomes of 1625 Patients With Primary Aldosteronism Subtyped With Adrenal Vein Sampling. Hypertension. 2019 Oct;74(4):800-808. doi: 10.1161/HYPERTENSIONAHA.119.13463. Epub 2019 Sep 3.
• Kempers MJ, Lenders JW, van Outheusden L, van der Wilt GJ, Schultze Kool LJ, Hermus AR, Deinum J. Systematic review: diagnostic procedures to differentiate unilateral from bilateral adrenal abnormality in primary aldosteronism. Ann Intern Med. 2009 Sep 1;151(5):329-37. doi: 10.7326/0003-4819-151-5-200909010-00007.
• 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 handbook. Ann Endocrinol (Paris). 2016 Jul;77(3):179-86. doi: 10.1016/j.ando.2016.05.001. Epub 2016 Jun 15.
• Heinze B, Fuss CT, Mulatero P, Beuschlein F, Reincke M, Mustafa M, Schirbel A, Deutschbein T, Williams TA, Rhayem Y, Quinkler M, Rayes N, Monticone S, Wild V, Gomez-Sanchez CE, Reis AC, Petersenn S, Wester HJ, Kropf S, Fassnacht M, Lang K, Herrmann K, Buck AK, Bluemel C, Hahner S. Targeting CXCR4 (CXC Chemokine Receptor Type 4) for Molecular Imaging of Aldosterone-Producing Adenoma. Hypertension. 2018 Feb;71(2):317-325. doi: 10.1161/HYPERTENSIONAHA.117.09975. Epub 2017 Dec 26.
• Ding J, Zhang Y, Wen J, Zhang H, Wang H, Luo Y, Pan Q, Zhu W, Wang X, Yao S, Kreissl MC, Hacker M, Tong A, Huo L, Li X. Imaging CXCR4 expression in patients with suspected primary hyperaldosteronism. Eur J Nucl Med Mol Imaging. 2020 Oct;47(11):2656-2665. doi: 10.1007/s00259-020-04722-0. Epub 2020 Mar 23.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: PET CT; Primary aldosteronism; Adrenal venous sampling
• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Hyperaldosteronism
• Other Study ID Numbers: 2021-553

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No