NCT06581744

Brief Summary

Primary aldosteronism (PA) is the most common endocrine cause of hypertension. 68Ga-pentixafor PET/CT possesses a relatively high sensitivity and specificity for Aldosterone producing adenoma (APA) detection. However, 68Ga is usually eluted from a 68Ge-68Ga generator, only a small amount of isotopes can be achieved once time. \[18F\]AlF-chelation is a promising strategy that would solve these issues. 18F labeled Pentixafor-Based Imaging Agent(\[18F\]AlF-NOTA-Pentixather) has been reported by Andreas Poschenrieder. \[18F\]AlF-NOTA-Pentixather displayed high and CXCR4-specific in vivo uptake in Daudi xenografts (13.9%±0.8% injected dose per gram \[ID/g\] at 1 hour post injection\[p.i.\]). But to date 18F-Pentixather has not been studied in humans. In this program the investigators will estimate the radiation dosimetry of \[18F\]AlF-NOTA-Pentixather, evaluate the sensitivity and specificity of the \[18F\]AlF-NOTA-Pentixather as a probe for APA.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress93%
Jun 2024Jun 2026

Study Start

First participant enrolled

June 12, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

August 27, 2024

Last Update Submit

August 29, 2024

Conditions

Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

Keywords

Primary aldosteronismRadiation Dosimetry18F-Pentixather

Outcome Measures

Primary Outcomes (2)

  • Measurement of radiation dosimetry and biodistribution of 18F-Pentixather determined with PET/CT in Patients with PA

    Images were acquired using a Biograph Truepoint 64 PET/CT scanner (Siemens, Erlangen, Germany).The dosimetry analysis was performed using 3d-slicer（version 5.6.1, with slicerOpenDose3D module (https://gitlab.com/opendose/opendose3d). OpenDose: open access resources for nuclear medicine dosimetry (www.opendose.org).

    6 month

  • Analyze the specificity and sensitivity of 18F-pentixather PET/CT for the diagnosis of APA

    Compare the 18F-Pentixather SUVmax with the CXCR4，CYP11B2 immunohistochemical score. Calculate the sensitivity and specificity of 18F-pentixafor PET/CT results for an indication of APA, IAH, or NFA lesions.

    3 years

Study Arms (1)

hyperaldosteronism

EXPERIMENTAL

Intravenous inject 18F-Pentixather，perform PET/CT imaging at the designated time

Other: [18F]AlF-NOTA-Pentixather

Interventions

[18F]AlF-NOTA-PentixatherOTHER

inject 185\~370MBq \[18F\]AlF-NOTA-Pentixather

hyperaldosteronism

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with primary aldosteronism and willing to undergo surgery
  • Clinically highly suspected of primary aldosteronism, but the diagnostic test cannot clearly identify the patients
  • Postoperative recurrence in patients with primary aldosteronism

You may not qualify if:

  • Pregnant and lactating women.
  • Patients with poor autonomous behavior ability, severe claustrophobia, and critically ill patients requiring life support who are unable to cooperate in completing the examination.
  • There are other situations where patients are not suitable for this examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116022, China

RECRUITING

Related Publications (2)

  • Zheng Y, Long T, Peng N, Zhen M, Ye Q, Zhang Z, He Y, Chen Z, Gan Y, Luo M, Li C, Liu Z, Guo M, Wang M, Luo X, Hu S, Liu L, Jiang T. The Value of Targeting CXCR4 With 68Ga-Pentixafor PET/CT for Subtyping Primary Aldosteronism. J Clin Endocrinol Metab. 2023 Dec 21;109(1):171-182. doi: 10.1210/clinem/dgad421.

    PMID: 37477496RESULT

  • Gao Y, Ding J, Cui Y, Li T, Sun H, Zhao D, Zhang Y, Huo L, Tong A. Functional nodules in primary aldosteronism: identification of CXCR4 expression with 68Ga-pentixafor PET/CT. Eur Radiol. 2023 Feb;33(2):996-1003. doi: 10.1007/s00330-022-09058-x. Epub 2022 Sep 7.

    PMID: 36070092RESULT

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System Diseases

Central Study Contacts

Fangfang Sun, MD

CONTACT

18098876916sf.f@163.com

Wei Song, PHD

CONTACT

18098875773songwei8124@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Pharmacist

Study Record Dates

First Submitted

August 27, 2024

First Posted

September 3, 2024

Study Start

June 12, 2024

Primary Completion

December 31, 2024

Study Completion (Estimated)

June 30, 2026

Last Updated

September 3, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)