Clinical trial NCT07027254: PETAL Trial: Impact of Gallium-68 Pentixafor PET-CT on Surgical Outcomes in Primary Aldosteronism
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
First posted: 2025-06-18
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Primary aldosteronism (PA) is a common cause of secondary hypertension. Accurate subtype classification (unilateral vs. bilateral) is essential to determine whether patients should receive adrenalectomy or medical therapy. AVS is the current gold standard but has limitations, including its invasiveness, technical difficulty, and risk of failure. Recently, non-invasive imaging techniques such as 68Ga-pentixafor PET/CT and 11C-metomidate PET/CT have emerged as promising alternatives for subtype classification. These PET-based methods target molecular markers (e.g., CXCR4, CYP11B2) and show moderate to high concordance rates with AVS (66.7%-90% for pentixafor). However, there is insufficient prospective evidence on whether these modalities can improve treatment outcomes. This randomized controlled trial aims to assess whether adding 68Ga-pentixafor PET/CT to standard AVS improves surgical outcomes in patients with unilateral PA. Participants are randomized 1:1 to undergo either AVS alone or AVS plus 68Ga-pentixafor PET/CT. Additionally, 11C-metomidate PET/CT is performed in the intervention arm purely for research purposes and will not influence treatment decisions. By improving the precision of subtype classification, this study aims to improve patient selection for adrenalectomy, and ultimately enhance clinical outcomes in primary aldosteronism.

Eligibility criteria: 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

Primary outcomes:
measure: Biochemical remission rate after adrenalectomy (surgery group only)
timeFrame: 6 months after adrenalectomy
Secondary outcomes:
measure: Clinical remission rate after adrenalectomy or initiation of medical therapy
timeFrame: 6 months after treatment (surgery or medication)
measure: Agreement rate between PET/CT imaging and adrenal venous sampling (AVS)
timeFrame: 6 months after treatment (surgery or medication)
measure: Concordance between AVS-based lateralization and immunohistochemical (IHC) expression of CXCR4 and CYP11B2
timeFrame: 6 months after treatment
measure: Concordance between PET/CT-based lateralization and immunohistochemical (IHC) expression of CXCR4 and CYP11B2
timeFrame: 6 months after treatment
measure: Correlation between the AVS-derived lateralization index and the SUVmax ratio on PET/CT
timeFrame: 6 months after treatment
measure: Change in plasma aldosterone concentration/aldosterone-to-renin ratio (ARR)
timeFrame: Baseline and 6 months after treatment
measure: Rate of blood pressure normalization
timeFrame: 6 months after treatment
measure: Change in antihypertensive medication use
timeFrame: Baseline and 6 months after treatment
measure: Change in serum potassium level
timeFrame: Baseline and 6 months after treatment
measure: Frequency and percentage of histologic subtype classification in resected adrenal tissue
timeFrame: 3 months after adrenalectomy
measure: Size of resected adrenal tumors
timeFrame: 3 months after adrenalectomy
measure: Correlation between somatic mutations and PET/CT SUVmax ratio
timeFrame: 3 months after adrenalecotmy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Su-jin Kim, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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