Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
ID07027254

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)

Led by Seoul National University Hospital · Updated on 2025-06-18

90

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

Sponsors

S

Seoul National University Hospital

Lead Sponsor

S

Samsung Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the clinical usefulness of adding gallium-68 pentixafor PET/CT imaging to the standard adrenal venous sampling (AVS) procedure for managing primary aldosteronism (PA). This condition causes secondary hypertension, and accurate identification of whether PA affects one adrenal gland or both is crucial for deciding between surgery or medication. This randomized controlled trial aims to see if combining 68Ga-pentixafor PET/CT with AVS improves surgical outcomes for patients with unilateral PA compared to AVS alone. Participants are randomly assigned to one of two groups: one receiving the standard AVS procedure alone, and the other receiving AVS plus 68Ga-pentixafor PET/CT imaging. Additionally, those in the intervention group undergo 11C-metomidate PET/CT scans for research purposes only, which do not influence treatment decisions. The study focuses on improving the precision of subtype classification to better select patients for adrenalectomy. During the study, participants undergo imaging and sampling procedures before treatment. Researchers will collect data on biochemical remission rates six months after adrenalectomy in the surgery group, as well as clinical remission rates after surgery or medical therapy. They will also assess the agreement between imaging and AVS results, correlate imaging findings with tissue analysis, and monitor changes in blood pressure, medication use, and lab values. The overall goal is to enhance treatment decisions and outcomes for people with primary aldosteronism.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 19 years or older
  • Diagnosed with primary aldosteronism according to 2016 Endocrine Society guidelines
  • Underwent adrenal CT scan
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Women who are pregnant, breastfeeding, or may become pregnant
  • Refusal to undergo surgery
  • Inability or refusal to undergo 68Ga-Pentixafor PET/CT, 11C-Metomidate PET/CT, or adrenal venous sampling (AVS)
  • Refusal or adverse effects from dexamethasone premedication needed for 11C-Metomidate PET/CT
  • History of open abdominal or retroperitoneal surgery on the side planned for adrenalectomy
  • Any condition deemed unsuitable for the study by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Up to 1 week

Participants undergo adrenal venous sampling (AVS) with or without 68Ga-pentixafor PET/CT imaging to assess adrenal aldosterone production and determine treatment eligibility.

1 to 2 visits depending on assigned imaging procedures

Treatment

Duration - Up to 6 months

Participants receive treatment based on subtype classification determined by diagnostic evaluation, including adrenalectomy surgery or medical therapy.

Visits as needed for surgery and medical therapy management

Follow-up

Duration - 6 months after treatment

Participants are monitored for clinical and biochemical remission, changes in blood pressure, medication use, and other outcomes after treatment.

Approximately 3 follow-up visits over 6 months

Trial Site Locations

Total: 2 locations

1

Samsung Medical Center

Seoul, Gangnam-gu, South Korea, 06351

Actively Recruiting

2

Seoul National University Hospital

Seoul, Jongno-gu, South Korea, 03080

Actively Recruiting

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Research Team

S

Seungho Lee, M.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Evaluation of the sensitivity and specificity of (11)C-metomidate positron emission tomography (PET)-CT for lateralizing aldosterone secretion by Conn's adenomas.

Timothy J Burton, Isla S Mackenzie, Kottekkattu Balan...

https://pubmed.ncbi.nlm.nih.gov/22112805

Adrenal Venous Sampling in Patients With Positive Screening but Negative Confirmatory Testing for Primary Aldosteronism.

Hironobu Umakoshi, Mitsuhide Naruse, Norio Wada...

https://pubmed.ncbi.nlm.nih.gov/26975712

The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline.

John W Funder, Robert M Carey, Franco Mantero...

https://pubmed.ncbi.nlm.nih.gov/26934393