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

Primary Aldosteronism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05131061
• Other study ID #: 2021-553
• Status: Completed
• Start date: November 11, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: July 2022
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 31, 2022
• Est. primary completion date: May 1, 2022
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Aldosteronism

Intervention

Diagnostic Test:
• 68Ga-Pentixafor PET/CT imaging
68Ga-Pentixafor PET/CT imaging

Locations

Country	Name	City	State
China	The First Affilated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Qifu Li	The Affiliated Hospital Of Southwest Medical University

Country where clinical trial is conducted

China, 

References & Publications (11)

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, Ménégaux F, Mounier-Véhier C, Nussberger J, Pagny JY, Pechère A, Plouin — View Citation

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. — View Citation

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 Ma — View Citation

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, Buc — View Citation

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; — View Citation

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 — View Citation

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 posit — View Citation

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, M — View Citation

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, M — View Citation

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 A — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)