PETAL Trial: Impact of Gallium-68 Pentixafor PET-CT on Surgical Outcomes in Primary Aldosteronism

NCT07027254 | Recruiting DMC

• 1 other identifier: 2502-040-1612
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a randomized controlled trial to assess the clinical utility of gallium-68 pentixafor PET/CT in the management of primary aldosteronism (PA). We aim to evaluate whether the addition of 68Ga-pentixafor PET/CT to standard adrenal venous sampling (AVS) improves surgical outcomes in patients with unilateral PA.

Conditions

Primary Aldosteronism; Secondary Hypertension; Aldosterone-Producing Adenoma; Idiopathic Hyperaldosteronism; Adrenalectomy

Keywords

Primary aldosteronism; Gallium-68 pentixafor; 11C-metomidate; PET/CT; adrenal venous sampling; PASO; PAMO; Adrenalectomy

Outcome Measures

Primary Outcomes (1)

• Biochemical remission rate after adrenalectomy (surgery group only)

  Number of participants achieving biochemical success as defined by PASO criteria will be assessed. Biochemical success is defined as normalization or improvement in aldosterone-to-renin ratio (ARR) and correction of hypokalemia without potassium supplementation in patients with unilateral primary aldosteronism who underwent adrenalectomy.

  6 months after adrenalectomy

Secondary Outcomes (12)

• Clinical remission rate after adrenalectomy or initiation of medical therapy

  6 months after treatment (surgery or medication)

• Agreement rate between PET/CT imaging and adrenal venous sampling (AVS)

  6 months after treatment (surgery or medication)

• Concordance between AVS-based lateralization and immunohistochemical (IHC) expression of CXCR4 and CYP11B2

  6 months after treatment

• Concordance between PET/CT-based lateralization and immunohistochemical (IHC) expression of CXCR4 and CYP11B2

  6 months after treatment

• Correlation between the AVS-derived lateralization index and the SUVmax ratio on PET/CT

  6 months after treatment

Study Arms (2)

AVS + 68Ga-pentixafor PET/CT (+ 11C-metomidate PET/CT)

EXPERIMENTAL

Intervention: Diagnostic Imaging: 68Ga-pentixafor PET/CT With 68Ga-pentixafor PET/CT imaging added to AVS for lateralization Subset only: 11C-metomidate PET/CT (for research use only, not used in treatment decisions)

Diagnostic Test: 68Ga-pentixafor PET/CT

AVS only

NO INTERVENTION

No PET/CT Without 68Ga-pentixafor PET/CT imaging; AVS only (Gold standard)

Interventions

68Ga-pentixafor PET/CT DIAGNOSTIC_TEST

Diagnostic PET/CT imaging using gallium-68 labeled pentixafor to assess adrenal CXCR4 expression in patients with primary aldosteronism. The imaging is performed prior to treatment allocation and used to assist lateralization of aldosterone production when combined with adrenal venous sampling (AVS).

AVS + 68Ga-pentixafor PET/CT (+ 11C-metomidate PET/CT)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥19 years
• Diagnosed with PA per 2016 Endocrine Society guidelines
• Underwent adrenal CT
• Signed informed consent

You may not qualify if:

• Women who are pregnant, breastfeeding, or may become pregnant
• Individuals who refuse to undergo surgery
• Individuals for whom 68Ga-Pentixafor PET/CT, 11C-Metomidate PET/CT, or adrenal venous sampling (AVS) is not feasible or is refused due to underlying conditions
• Individuals who refuse or experience adverse effects from dexamethasone premedication required for 11C-Metomidate PET/CT
• Individuals with a history of abdominal open surgery or retroperitoneal surgery on the same side as the planned adrenalectomy
• Any individual deemed unsuitable for the study at the discretion of the investigator

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Samsung Medical Center: collaborator

Study Sites (2)

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

Related Publications (10)

• Kim JH, Ahn CH, Kim SJ, Lee KE, Kim JW, Yoon HK, Lee YM, Sung TY, Kim SW, Shin CS, Koh JM, Lee SH. Outcome-Based Decision-Making Algorithm for Treating Patients with Primary Aldosteronism. Endocrinol Metab (Seoul). 2022 Apr;37(2):369-382. doi: 10.3803/EnM.2022.1391. Epub 2022 Apr 14.

  PMID: 35417953 BACKGROUND

• Ren X, Cheng G, Wang Z. Advances in the molecular imaging of primary aldosteronism. Ann Nucl Med. 2023 Aug;37(8):433-441. doi: 10.1007/s12149-023-01851-y. Epub 2023 Jul 2.

  PMID: 37393373 BACKGROUND

• Soinio M, Luukkonen AK, Seppanen M, Kemppainen J, Seppanen J, Pienimaki JP, Leijon H, Vesterinen T, Arola J, Lantto E, Helin S, Tikkanen I, Metso S, Mirtti T, Heiskanen I, Norvio L, Tiikkainen M, Tikkanen T, Sane T, Valimaki M, Gomez-Sanchez CE, Porsti I, Nuutila P, Nevalainen PI, Matikainen N. Functional imaging with 11C-metomidate PET for subtype diagnosis in primary aldosteronism. Eur J Endocrinol. 2020 Dec;183(6):539-550. doi: 10.1530/EJE-20-0532.

  PMID: 33055298 BACKGROUND

• Burton TJ, Mackenzie IS, Balan K, Koo B, Bird N, Soloviev DV, Azizan EA, Aigbirhio F, Gurnell M, Brown MJ. Evaluation of the sensitivity and specificity of (11)C-metomidate positron emission tomography (PET)-CT for lateralizing aldosterone secretion by Conn's adenomas. J Clin Endocrinol Metab. 2012 Jan;97(1):100-9. doi: 10.1210/jc.2011-1537. Epub 2011 Nov 23.

  PMID: 22112805 BACKGROUND

• 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 BACKGROUND

• Umakoshi H, Naruse M, Wada N, Ichijo T, Kamemura K, Matsuda Y, Fujii Y, Kai T, Fukuoka T, Sakamoto R, Ogo A, Suzuki T, Nanba K, Tsuiki M; WAVES-J Study Group. Adrenal Venous Sampling in Patients With Positive Screening but Negative Confirmatory Testing for Primary Aldosteronism. Hypertension. 2016 May;67(5):1014-9. doi: 10.1161/HYPERTENSIONAHA.115.06607. Epub 2016 Mar 14.

  PMID: 26975712 BACKGROUND

• Rossi GP, Auchus RJ, Brown M, Lenders JW, Naruse M, Plouin PF, Satoh F, Young WF Jr. An expert consensus statement on use of adrenal vein sampling for the subtyping of primary aldosteronism. Hypertension. 2014 Jan;63(1):151-60. doi: 10.1161/HYPERTENSIONAHA.113.02097. Epub 2013 Nov 11.

  PMID: 24218436 BACKGROUND

• Hannemann A, Wallaschofski H. Prevalence of primary aldosteronism in patient's cohorts and in population-based studies--a review of the current literature. Horm Metab Res. 2012 Mar;44(3):157-62. doi: 10.1055/s-0031-1295438. Epub 2011 Dec 1.

  PMID: 22135219 BACKGROUND

• 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.

  PMID: 17161262 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Hyperaldosteronism; Adrenocortical Adenoma

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Adrenal Cortex Diseases

Study Officials

• Su-jin Kim, M.D, Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seungho Lee, M.D

CONTACT

82-10-8629-9209; ganymedes10@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The nuclear medicine physician interpreting PET/CT scans is masked to AVS results. However, participants and treating clinicians are not blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Surgery, Seoul National University Hospital

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 18, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)