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

NCT06238232 | Completed DMC

• 1 other identifier: GAPA study
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Primary Aldosteronism

Keywords

Adrenal venous sampling; 68Ga-Pentixafor PET/CT; multicenter randomized noninferiority clinical trial; Primary aldosteronism

Outcome Measures

Primary Outcomes (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.

  At 6 months of follow-up.

Secondary Outcomes (2)

• The proportion of complete clinical success

  At 6 months of follow-up.

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

  At 6 months of follow-up.

Other Outcomes (2)

• Adverse events

  At 6 month of follow-up.

• Health Economics Outcomes

  At 6 months of follow-up.

Study Arms (2)

68Ga-Pentixafor PET/CT group

EXPERIMENTAL

Patients divided into 68Ga-Pentixafor PET/CT group need to undergo 68Ga-Pentixafor PET/CT examination and guide subsequent treatment based on the results

Diagnostic Test: 68Ga-Pentixafor PET/CT

AVS group

NO INTERVENTION

Patients divided into AVS group need to undergo AVS to guide subsequent treatment based on the results

Interventions

68Ga-Pentixafor PET/CT DIAGNOSTIC_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.

68Ga-Pentixafor PET/CT group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria:
• Ability to understand the trial procedures and provide written informed consent.
• Age 18 to 70 years.
• Hypertension with a confirmed diagnosis of primary aldosteronism.
• Adrenal gland CT or MRI scan showing an adrenal nodule of 1 cm or larger.
• 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.

You may not qualify if:

• Participants will be excluded if any of the following criteria are met:
• Autonomous cortisol secretion,defined as a serum cortisol levels ≥ 50 nmol/L after a 1-mg overnight dexamethasone suppression test.
• 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.
• Compliacted with other secondary hypertension (such as Cushing's syndrome, renal artery stenosis, but not including obstructive sleep apnea syndrome).
• 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.
• Adrenal nodules with imaging characteristics suggestive of pheochromocytoma, adrenocortical carcinoma, adrenal cysts, adrenal hematomas, or adrenal myelolipomas.
• Active malignant disease.
• Previous adrenal surgery.
• Adrenal insufficiency requiring glucocorticoid replacement therapy.
• Long-term glucocorticoid therapy that cannot be discontinued.
• Allergy or intolerance to contrast media or contraindication to AVS.
• Pregnancy or lactation.
• Alcohol or drug abuse, or psychiatric illness that would interfere with trial participation.
• New York Heart Association class III or IV heart failure.
• Hospitalization for worsening chronic heart failure within the previous 3 months.

Sponsors & Collaborators

• Chongqing Medical University: lead
• The People's Hospital of Chuxiong Yi Autonomous Prefecture: collaborator
• Second Affiliated Hospital, Zhejiang University, School of Medicine: collaborator
• Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University: collaborator
• Tongji Hospital, Tongji Medical College, HUST: collaborator
• The Affiliated Hospital Of Southwest Medical University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• Changzhi Medical College: collaborator
• Xiangya Hospital of Central South University: collaborator

Study Sites (1)

The First Affilated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Related Publications (14)

• 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.

  PMID: 39626105 RESULT

• 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 RESULT

• 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.

  PMID: 32327102 RESULT

• 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.

  PMID: 32890265 RESULT

• 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.

  PMID: 29129575 RESULT

• 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.

  PMID: 29987110 RESULT

• 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 RESULT

• 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.

  PMID: 27315757 RESULT

• 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.

  PMID: 21828936 RESULT

• 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.

  PMID: 15657580 RESULT

• 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.

  PMID: 26199389 RESULT

• 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 RESULT

• 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.

  PMID: 36795418 RESULT

• 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.

  PMID: 32206838 RESULT

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Qifu Li, MD, PhD

  First Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

• Shumin Yang, MD, PhD

  First Affiliated Hospital of Chongqing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Biochemical and clinical outcomes were independently assessed by 2 evaluators who were not involved in subtype classification or treatment decisions and were blinded to the randomized diagnostic strategy. Disagreements were resolved by a third independent evaluator.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: February 2, 2024
• Study Start: January 9, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)