68Ga-Pentixafor PET/CT for the Subtyping Diagnosis of Primary Aldosteronism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-11

Study Completion Date

2022-05-31

Brief Summary

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To evaluate the value of 68Ga-Pentixafor PET/CT in the diagnosis of primary aldosteronism subtype

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Detailed Description

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This is a prospective study. We will enroll 100 patients with definite diagnosis of PA using adrenal venous sampling(AVS) as the gold standard for subtype to evaluate the value of 68Ga-pentixaforPET/CT in the diagnosis of PA.

Conditions

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Primary Aldosteronism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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unilateral primary aldosteronism(UPA)

PA confirmatory tests was positive; successful intubation (SI ≥ 3) and LI ≥ 4; If LI between 2 and 4, should be combined with contralateral inhibition index \< 1 or CT indicate typical adenomas on the dominant side.

68Ga-Pentixafor PET/CT imaging

Intervention Type DIAGNOSTIC_TEST

68Ga-Pentixafor PET/CT imaging

bilateral adrenal hyperplasia(BAH)

PA confirmatory tests was positive; successful intubation (SI ≥ 3) and LI \< 2; or LI between 2 and 4 but does not meet the UPA conditions

68Ga-Pentixafor PET/CT imaging

Intervention Type DIAGNOSTIC_TEST

68Ga-Pentixafor PET/CT imaging

Interventions

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68Ga-Pentixafor PET/CT imaging

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. PA diagnosis confirmed by at least one confirmatory test
2. willingness to undergo AVS and surgery
3. informed consent to participate in the study.

Exclusion Criteria

1. PA patients who met guideline criteria for bypassing AVS \[i.e. younger than 35 years old, with typical APA characteristics (plasma aldosterone \>300pg/ml, plasma renin \< 2·5mIU/l, serum potassium \<3·5mmol/l, CT indicated unilateral 1cm low-density adenoma);
2. failed adrenal vein cannulation during AVS;
3. Subtyping diagnosis was inconclusive based on AVS results (e.g. aldosterone/cortisol ratio in bilateral adrenal veins lower than the peripheral vein, or missing data);
4. pregnant or lactating women;
5. patients with a history of uncontrolled malignant tumor;
6. concurrent Cushing's syndrome \[including mild autonomous cortisol secretion: cortisol after 1mg dexamethasone suppression test (DST)\>138 nmol/l or cortisol after 2mg DST \>50 nmol/l or cortisol after 1mg DST 50-138 nmol/l plus adrenocorticotrophic hormone (ACTH)\<10pg/ml;
7. diagnosis of familial hyperaldosteronism;
8. imaging characteristics suggestive of pheochromocytoma or adrenal cortical carcinoma;
9. unsuitable for surgery, such as heart failure with New York Heart Association (NYHA) class III or IV, severe anemia (Hemoglobin\<60g/L), stroke or acute coronary syndrome within 3 months, severe ascites and cirrhosis, estimated glomerulus filtration rate\<30ml/min/m;
10. alcohol or drug abuse and mental disorders.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No