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

Sponsor
Qifu Li (Other)
Overall Status
Completed
CT.gov ID
NCT05131061
Collaborator
The Affiliated Hospital Of Southwest Medical University (Other)
100
Enrollment
1
Location
6.6
Actual Duration (Months)
15.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 68Ga-Pentixafor PET/CT imaging

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
68Ga-Pentixafor PET/CT for the Subtyping Diagnosis of Primary Aldosteronism: A Prospective Diagnostic Accuracy Study
Actual Study Start Date :
Nov 11, 2021
Actual Primary Completion Date :
May 1, 2022
Actual Study Completion Date :
May 31, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Diagnostic Test: 68Ga-Pentixafor PET/CT imaging
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

Diagnostic Test: 68Ga-Pentixafor PET/CT imaging
68Ga-Pentixafor PET/CT imaging

Outcome Measures

Primary Outcome Measures

  1. accuracy of 68Ga-PentixaforPET/CT in subtyping diagnosis of PA [at the end of study(the last enrolled patient completed a 3-month follow-up)]

    AUC

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
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;

  1. diagnosis of familial hyperaldosteronism;

  2. imaging characteristics suggestive of pheochromocytoma or adrenal cortical carcinoma;

  3. 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;

  4. alcohol or drug abuse and mental disorders.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affilated Hospital of Chongqing Medical University Chongqing Chongqing China 400016

Sponsors and Collaborators

  • Qifu Li
  • The Affiliated Hospital Of Southwest Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qifu Li, Primary investigator, Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT05131061
Other Study ID Numbers:
  • 2021-553
First Posted:
Nov 23, 2021
Last Update Posted:
Jul 15, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Qifu Li, Primary investigator, Chongqing Medical University
PET CT; Primary aldosteronism; Adrenal venous sampling
Additional relevant MeSH terms:
Hyperaldosteronism

Study Results

No Results Posted as of Jul 15, 2022