Outcome of 68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Primary Aldosteronism

Primary Aldosteronism Clinical Trial

— GAPA  

Official title:

68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling to Determine Treatment in Primary Aldosteronism: A Multicenter Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06238232
• Other study ID #: GAPA study
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2024
• Source: Chongqing Medical University
• Contact: Qifu Li, PhD
• Phone: +86 023-89011552
• Email: liqifu[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

Description:

This is a randomized study 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

(1)Getting the written informed consent (2)ARR =20 (pg/ml)/ (µIU/ml) or ARR = 30(ng/dL)/(ng/ml/hr) plus at least one positive PA confirmatory test (CCT, SSIT).

(3)Patients who are willing to undergo surgery. (4)Patients with hypertension aged 18-70 years. (5)CT or MRI scan of the adrenal glands with nodule (=1cm). Exclusion criteria

1. Combined with autonomous cortisol secretion, cortisol after 1mg dexamethasone suppression test (DST) =50 nmol/l.

2. PA patients who meet the by-passing AVS criteria [i.e., younger than 35 years old, spontaneous hypokalemia, adrenal CT indicated unilateral low-density adenoma (=1cm), plasma aldosterone >300pg/ml]

3. Suspicion of familial hyperaldosteronism or Liddle syndrome. [i.e., age <20 years, hypertension and hypokalemia, or with family history]

4. Suspicion of pheochromocytoma or adrenal carcinoma.

5. Patients with actively malignant tumor.

6. Patients who have adrenalectomy history or with adrenocortical insufficiency.

7. Long-term use of glucocorticoids.

8. Pregnant or lactating women; with alcohol or drug abuse and mental disorders.

9. Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV; History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 3 months; Severe anemia (Hb<60g/L); Serious liver dysfunction or chronic kidney disease aspartate aminotransferase (AST) or alanine transaminase (ALT) >3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2); Systemic Inflammatory Response Syndrome (SIRS); Uncontrolled diabetes (FBG=13.3 mmol/L); Obesity (BMI=35 kg/m²) or Underweight (BMI=18 kg/m²); Untreated aneurysm; Other comorbidity potentially interfering with treatment

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Aldosteronism

Intervention

Diagnostic Test:
• 68Ga-Pentixafor PET/CT
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.

Locations

Country	Name	City	State
China	The First Affilated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (10)

Lead Sponsor

Collaborator

Qifu Li

Changzhi Medical College, Second Affiliated Hospital, School of Medicine, Zhejiang University, The Affiliated Hospital Of Southwest Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Zhengzhou University, The Third Xiangya Hospital of Central South University, Tongji Hospital, West China Hospital, Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (13)

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 — View Citation

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. — View Citation

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 Ma — View Citation

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, Buc — View Citation

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 Tomo — View Citation

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. — View Citation

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 — View Citation

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 posit — View Citation

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. E — View Citation

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, M — View Citation

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. — View Citation

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 A — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of complete biochemical remission	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	The proportion of complete clinical remission	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	In surgical population, the proportion of complete biochemical remission	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	In surgical population, the proportion of complete clinical remission	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	Daily defined doses (DDD) of antihypertensive agents	Prescribed daily dose (DDD) of antihypertensive drugs (including MRA) in each group after 6-12 months of follow-up.	At 6-12 months of follow-up.
Secondary	Total cost of diagnosis and treatment	After patients are determined to be enrolled, treatment costs incurred for the diagnostic process will be calculated for each subject. This includes CT,AVS or PET/CT, surgery, medications, etc.	At baseline and 6 months of follow-up.
Secondary	Health Related Quality of Life	The quality of life in our patients may be influenced in different ways.AVS is an invasive test, PET/CT does not require any preparation of the patient before the test. Questionnaires of QOL-BREF will be conducted by patients before treatment and at 6-12 months follow-up in each group.This will allow for a detailed analysis of the impact of the two strategies on the quality of life of the patients.	At baseline and 6 months of follow-up.
Secondary	Comparison of adverse events	The occurrence of adverse events was recorded, including PET/CT contrast agent allergy, adrenal vein hemorrhage and related adrenal insufficiency, hypertensive emergency, anaphylactic shock, venous thrombosis, pulmonary embolism, etc.	At baseline and 6 month of follow-up.