Clinical trial · Interventional
PETAL Trial: Impact of Gallium-68 Pentixafor PET-CT on Surgical Outcomes in Primary Aldosteronism
A Randomized Controlled Trial to Evaluate the Effect of Gallium-68 Pentixafor PET-CT on Surgical Outcomes in Patients With Primary Aldosteronism (The PETAL Trial)
NCT07027254CI-TRIAL-00091130recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adrenalectomy | — | UNRESOLVED | — |
| Aldosterone-Producing Adenoma | — | UNRESOLVED | — |
| Idiopathic Hyperaldosteronism | — | UNRESOLVED | — |
| Primary Aldosteronism | — | UNRESOLVED | — |
| Secondary Hypertension | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-pentixafor PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AVS + 68Ga-pentixafor PET/CT (+ 11C-metomidate PET/CT)
- description
- 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)
- interventionNames
- Diagnostic Test: 68Ga-pentixafor PET/CT
- type
- NO_INTERVENTION
- label
- AVS only
- description
- No PET/CT Without 68Ga-pentixafor PET/CT imaging; AVS only (Gold standard)
Primary outcomes (1)
- measure
- Biochemical remission rate after adrenalectomy (surgery group only)
- timeFrame
- 6 months after adrenalectomy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥19 years * Diagnosed with PA per 2016 Endocrine Society guidelines * Underwent adrenal CT * Signed informed consent Exclusion Criteria: * 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
References
Publications (10)
- BACKGROUNDKim 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
- BACKGROUNDRen 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
- BACKGROUNDSoinio 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
- BACKGROUNDBurton 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
- BACKGROUNDHeinze 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
- BACKGROUNDUmakoshi 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.