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Primary AldosteronismGAPANCT06238232

68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Primary Aldosteronism: The GAPA Randomized Clinical Trial

A study testing 68Ga-Pentixafor PET/CT in people with Primary Aldosteronism, run by Chongqing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To compare the 68Ga-Pentixafor PET/CT and adrenal vein sampling on the long-term outcomes of primary aldosteronism (PA) patients with adrenal nodule (≥1cm) Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Primary Aldosteronism
What is being tested?
68Ga-Pentixafor PET/CT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
1 siteChina
Study dates
9 Jan 2024to 1 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

1 Inclusion Criteria

Participants must meet all of the following criteria:

  1. .Ability to understand the trial procedures and provide written informed consent.
  2. .Age 18 to 70 years.
  3. .Hypertension with a confirmed diagnosis of primary aldosteronism.
  4. .Adrenal gland CT or MRI scan showing an adrenal nodule of 1 cm or larger.
  5. .Willingness to undergo adrenalectomy if lateralizing primary aldosteronism is identified.

A confirmed diagnosis of primary aldosteronism will be defined as a positive screening result and at least one positive aldosterone suppression test. A positive screening result will be defined as an aldosterone-to-renin ratio of ≥20(pg/mL)/(mIU/L) or≥30 (ng/dL)/(ng/mL/hr). A positive aldosterone suppression test will be defined as a plasma aldosterone concentration of≥110 pg/mL after the captopril challenge test or ≥80pg/mL after the seated saline infusion test.

2 Exclusion Criteria

Participants will be excluded if any of the following criteria are met:

  1. .Autonomous cortisol secretion,defined as a serum cortisol levels ≥ 50 nmol/L after a 1-mg overnight dexamethasone suppression test.
  2. .Fulfillment of prespecified criteria for bypassing AVS, defined as age younger than 35 years, typical features of aldosterone-producing adenoma, plasma aldosterone concentration >300 pg/mL, spontaneous hypokalemia, and a unilateral low-density adrenal nodule >1 cm on CT.
  3. .Compliacted with other secondary hypertension (such as Cushing's syndrome, renal artery stenosis, but not including obstructive sleep apnea syndrome).
  4. .Onset of hypertension before 20 years of age with hypokalemia and a family history suggestive of familial hyperaldosteronism, Liddle syndrome, or another hereditary form of hypertension.
  5. . Adrenal nodules with imaging characteristics suggestive of pheochromocytoma, adrenocortical carcinoma, adrenal cysts, adrenal hematomas, or adrenal myelolipomas.
  6. .Active malignant disease.
  7. .Previous adrenal surgery.
  8. .Adrenal insufficiency requiring glucocorticoid replacement therapy.
  9. .Long-term glucocorticoid therapy that cannot be discontinued.
  10. .Allergy or intolerance to contrast media or contraindication to AVS.
  11. .Pregnancy or lactation.
  12. .Alcohol or drug abuse, or psychiatric illness that would interfere with trial participation.
  13. .New York Heart Association class III or IV heart failure.
  14. .Hospitalization for worsening chronic heart failure within the previous 3 months.
  15. .Stroke or acute coronary syndrome within the previous 3 months.
  16. .Severe anemia, defined as hemoglobin <6 g/dl.
  17. .Severe liver disease, defined as alanine aminotransferase ≥3 times the upper limit of the normal range.
  18. .Severe kidney disease, defined as dialysis treatment or an estimated glomerular filtration rate <30 mL/min/1.73 m².
  19. .Systemic inflammatory response syndrome.
  20. .Uncontrolled diabetes, defined as fasting blood glucose ≥13.3 mmol/L.
  21. .Severe obesity, defined as a body-mass index ≥35 kg/m², or underweight status, defined as a body-mass index ≤18 kg/m².
  22. .Untreated aneurysm or any other condition that, in the investigator's judgment, would interfere with safe participation or continued treatment for primary aldosteronism.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affilated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

Other trials in China

About this study

To compare the 68Ga-Pentixafor PET/CT and adrenal vein sampling on the long-term outcomes of primary aldosteronism (PA) patients with adrenal nodule (≥1cm)

Read the detailed description

This is a multicenter randomized noninferiority clinical trial involving patients with primary aldosteronism (PA) patients with adrenal nodule (≥1cm) who completed AVS or 68Ga-Pentixafor PET/CT.We will enroll 320 PA patients with adrenal nodule (≥1cm) .All paticipants will be randomized into 68Ga-Pentixafor PET/CT group(Intervention group) and AVS group(Control group) to compare the long-term outcomes of patients with PA.

Being tested
68Ga-Pentixafor PET/CT
Keywords
Adrenal venous sampling, 68Ga-Pentixafor PET/CT, multicenter randomized noninferiority clinical trial, Primary aldosteronism
Medical subject headings
Hyperaldosteronism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 68Ga-Pentixafor PET/CTDiagnostic test

    The patients had a normal diet with no special preparation before 68Ga-Pentixafor PET/CT imaging. The dosage of intravenously injected 68Ga-Pentixafor was calculated based on the patient's weight (1.85 MBq [0.05mCi]/kg). Local PET/CT scanning of the upper abdomen was performed on a hybrid PET/CT scanner at 10 minutes after the injection of the intravenous tracer, respectively.

Study groups in NCT06238232
Study groupRoleWhat they receive
68Ga-Pentixafor PET/CT groupExperimentalPatients divided into 68Ga-Pentixafor PET/CT group need to undergo 68Ga-Pentixafor PET/CT examination and guide subsequent treatment based on the results
Receives: Diagnostic Test: 68Ga-Pentixafor PET/CT
AVS groupNo interventionPatients divided into AVS group need to undergo AVS to guide subsequent treatment based on the results

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of complete biochemical rsuccess

    Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria.

    Measured: At 6 months of follow-up.

Secondary outcomes (2)

  1. The proportion of complete clinical success

    Complete clinical success was assessed according to PASO criteria based on blood pressure and antihypertensive medication use. The outcome was the proportion of participants with complete clinical success at 6-month follow-up after treatment.

    Measured: At 6 months of follow-up.

  2. The change in the Defined Daily Dose (DDD) of antihypertensive medications

    Prescribed The change in the Defined Daily Dose (DDD) of antihypertensive medications from baseline to 6-month after treatment.

    Measured: At 6 months of follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2024
  2. Study start9 Jan 2024
  3. Primary completion1 May 2026
  4. Study completion1 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06238232
Sponsor's protocol ID
GAPA study
Acronym
GAPA
Status last verified
Sep 2026
First submitted
4 Jan 2024
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang X, Song Y, Jing Y, Hu J, Shen H, Zhang A, He W, Feng Z, Yang Y, Pang H, Li Q, Yang S; Chongqing Primary Aldosteronism Study (CONPASS) Group; the. Comparison of Different Diagnostic Criteria of 68Ga-Pentixafor PET/CT for the Classification of Primary Aldosteronism. J Clin Endocrinol Metab. 2025 Jul 15;110(8):e2583-e2590. doi: 10.1210/clinem/dgae747.

    PubMed 39626105

  • 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.

    PubMed 17161262

  • 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 Apr 28;75(16):1913-1922. doi: 10.1016/j.jacc.2020.02.052.

    PubMed 32327102

  • 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 position statement and consensus of the Working Group on Endocrine Hypertension of the European Society of Hypertension. J Hypertens. 2020 Oct;38(10):1929-1936. doi: 10.1097/HJH.0000000000002520.

    PubMed 32890265

  • Monticone S, D'Ascenzo F, Moretti C, Williams TA, Veglio F, Gaita F, Mulatero P. Cardiovascular events and target organ damage in primary aldosteronism compared with essential hypertension: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2018 Jan;6(1):41-50. doi: 10.1016/S2213-8587(17)30319-4. Epub 2017 Nov 9.

    PubMed 29129575

  • Hundemer GL, Curhan GC, Yozamp N, Wang M, Vaidya A. Renal Outcomes in Medically and Surgically Treated Primary Aldosteronism. Hypertension. 2018 Sep;72(3):658-666. doi: 10.1161/HYPERTENSIONAHA.118.11568.

    PubMed 29987110

  • 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.

    PubMed 26934393

  • 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, Menegaux F, Mounier-Vehier C, Nussberger J, Pagny JY, Pechere A, Plouin PF, Reznik Y, Steichen O, Tabarin A, Zennaro MC, Zinzindohoue F, Chabre O. SFE/SFHTA/AFCE primary aldosteronism consensus: Introduction and handbook. Ann Endocrinol (Paris). 2016 Jul;77(3):179-86. doi: 10.1016/j.ando.2016.05.001. Epub 2016 Jun 15.

    PubMed 27315757

  • Nishikawa T, Omura M, Satoh F, Shibata H, Takahashi K, Tamura N, Tanabe A; Task Force Committee on Primary Aldosteronism, The Japan Endocrine Society. Guidelines for the diagnosis and treatment of primary aldosteronism--the Japan Endocrine Society 2009. Endocr J. 2011;58(9):711-21. doi: 10.1507/endocrj.ej11-0133. Epub 2011 Aug 9.

    PubMed 21828936

  • 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. doi: 10.1016/j.surg.2004.06.051.

    PubMed 15657580

  • Scala S. Molecular Pathways: Targeting the CXCR4-CXCL12 Axis--Untapped Potential in the Tumor Microenvironment. Clin Cancer Res. 2015 Oct 1;21(19):4278-85. doi: 10.1158/1078-0432.CCR-14-0914. Epub 2015 Jul 21.

    PubMed 26199389

  • 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.

    PubMed 29279316

  • Hu J, Xu T, Shen H, Song Y, Yang J, Zhang A, Ding H, Xing N, Li Z, Qiu L, Ma L, Yang Y, Feng Z, Du Z, He W, Sun Y, Cai J, Li Q, Chen Y, Yang S; Chongqing Primary Aldosteronism Study (CONPASS) Group. Accuracy of Gallium-68 Pentixafor Positron Emission Tomography-Computed Tomography for Subtyping Diagnosis of Primary Aldosteronism. JAMA Netw Open. 2023 Feb 1;6(2):e2255609. doi: 10.1001/jamanetworkopen.2022.55609.

    PubMed 36795418

  • 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. doi: 10.1007/s00259-020-04722-0. Epub 2020 Mar 23.

    PubMed 32206838

Questions about this trial

What is this clinical trial studying?

A study testing 68Ga-Pentixafor PET/CT in people with Primary Aldosteronism, run by Chongqing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of complete biochemical rsuccess (time frame: At 6 months of follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06238232, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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