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

NCT ID: NCT06238232

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-09
• Study Completion Date: 2027-12-31

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)

Detailed 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.

Conditions

Primary Aldosteronism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

68Ga-Pentixafor PET/CT group

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

Group Type: EXPERIMENTAL

68Ga-Pentixafor PET/CT

Intervention Type: 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.

AVS group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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).

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital Of Southwest Medical University

OTHER

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: collaborator

Tongji Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: collaborator

Changzhi Medical College

OTHER

Sponsor Role: collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

Qifu Li

OTHER

Sponsor Role: lead

Responsible Party

Qifu Li

Primary investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Qifu Li, PhD

Role: STUDY_CHAIR

the Chongqing Primary Aldosteronism Study (CONPASS) Group

Locations

The First Affilated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qifu Li, PhD

Role: CONTACT

liqifu@yeah.net

+86 023-89011552

Facility Contacts

Qifu Li, PhD

Role: primary

liqifu@yeah.net

023-89011552

Ying Song, M.D.

Role: backup

shuiyunying@126.com

023-89011552

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Other Identifiers

GAPA study

Identifier Type: -

Identifier Source: org_study_id