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

NCT05131061 | Completed DMC

• 1 other identifier: 2021-553
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Aldosteronism

Keywords

PET CT; Primary aldosteronism; Adrenal venous sampling

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

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

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

Interventions

68Ga-Pentixafor PET/CT imaging DIAGNOSTIC_TEST

68Ga-Pentixafor PET/CT imaging

bilateral adrenal hyperplasia(BAH); unilateral primary aldosteronism(UPA)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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);
• failed adrenal vein cannulation during AVS;
• 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);
• pregnant or lactating women;
• patients with a history of uncontrolled malignant tumor;
• 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;
• diagnosis of familial hyperaldosteronism;
• imaging characteristics suggestive of pheochromocytoma or adrenal cortical carcinoma;
• 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;
• alcohol or drug abuse and mental disorders.

Sponsors & Collaborators

• Qifu Li: lead
• The Affiliated Hospital Of Southwest Medical University: collaborator

Study Sites (1)

The First Affilated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Related Publications (11)

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  PMID: 17161262 RESULT

• 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.

  PMID: 28385310 RESULT

• 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 RESULT

• 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.

  PMID: 32890265 RESULT

• 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.

  PMID: 15657580 RESULT

• 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.

  PMID: 31476901 RESULT

• 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.

  PMID: 19721021 RESULT

• 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 RESULT

• 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.

  PMID: 27315757 RESULT

• 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.

  PMID: 29279316 RESULT

• 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.

  PMID: 32206838 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

fasting plasma were collected for each patient

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Primary investigator

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 23, 2021
• Study Start: November 11, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 31, 2022
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)