NCT05188872

Brief Summary

Primary aldosteronism is the most common cause of secondary hypertension. The two main types of primary aldosteronism are aldosteronoma(30%) and adrenal hyperplasia(60%). The gold standard that determines the diagnosis and treatment strategy of primary aldosteronism is adrenal vein sampling(AVS), but the success rate is only about 80%. Using CXCR4 as a probe for 68Ga-Pentixafor PET/CT imaging can guide the classification diagnosis and treatment strategy of primary aldosteronism, which is a favorable supplement to AVS. Superselective adrenal artery embolization(SAAE) and laparoscopy are the main operation treatments for primary aldosteronism. SAAE is an invasive interventional operation. It is a novel way to evaluate the changes in the structure and function of adrenal tissue pre-postoperative SAAE by using the changes in 68Ga-Pentixafor PET/CT imaging.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

4 years

First QC Date

August 30, 2021

Last Update Submit

September 15, 2023

Conditions

Positron-Emission Tomography

Outcome Measures

Primary Outcomes (1)

  • Standardized uptake value (SUV)

    Standardized uptake value (SUV) of 68Ga-Pentixafor for each target or suspected lesion of subject.

    through study completion,an average of 3 years

Secondary Outcomes (1)

  • SAAE treatment evaluation

    through study completion,an average of 3 years

Study Arms (1)

68Ga-Pentixafor

EXPERIMENTAL

Each subject receive a single intravenous injection of 68Ga-Pentixafor, and undergo PET/CT imaging within the specificed time

Diagnostic Test: 68Ga-Pentixafor

Interventions

68Ga-PentixaforDIAGNOSTIC_TEST

Each patient receive a single intravenous injection of 68Ga-Pentixafor, and undergo PET/CT scan within specified time.

Also known as: PET/CT scan
68Ga-Pentixafor

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult population (aged 18 years or order);
  • patients with suspected or new diagnosed Primary aldosteronism (supporting evidence may include MRI, CT, laboratory tests);
  • patients who had scheduled 68Ga-BNU-PSMA PET/CT scan;
  • patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee;
  • healthy volunteers(aged 18 years or order).

You may not qualify if:

  • patients with pregnancy;
  • the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

Related Publications (1)

  • Fang Z, Cai H, Zhang Q, Gong J, Zhou W, Xie L, Peng F. Comparative Analysis of Single-Path and Multipath Adrenal Venous Sampling in Primary Aldosteronism. J Interv Cardiol. 2023 Aug 12;2023:8670365. doi: 10.1155/2023/8670365. eCollection 2023.

    PMID: 37601238DERIVED

MeSH Terms

Interventions

Positron Emission Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Liangdi Xie, MD

    the First Affiliated Hospital, Fujian Medical University

    STUDY CHAIR

Central Study Contacts

Weibing Miao, MD

CONTACT

86-0591-87981618miaoweibing@126.com

Jinxiu Lin, MD

CONTACT

86-13799777113linjinxiu@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Nuclear Medicine

Study Record Dates

First Submitted

August 30, 2021

First Posted

January 12, 2022

Study Start

September 1, 2020

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)