NCT06086327

Brief Summary

Chemokine receptor CXCR4 was expressed in T cells and CXCR4-targeting molecular imaging- 68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of thymoma with higher accuracy. This prospective study is going to investigate whether metabolic characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, distinguish evaluation for thymoma.

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 P75+ for early_phase_1

Timeline
Completed

Started Jun 2023

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

June 22, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 17, 2023

Status Verified

June 1, 2023

Enrollment Period

1.5 years

First QC Date

October 11, 2023

Last Update Submit

October 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • SUVmax and SUVmean

    SUVsof focal lesions are measured on 68Ga-Pentixafor PET/CT. The SUVs of the blood pool and muscle are defined as the background activity on the condition that there is no focally hypermetabolic disease.

    through study completion, an average of 1.5 years

Secondary Outcomes (4)

  • Diagnostic value

    through study completion, an average of 1.5 years

  • Diagnostic value in special type of thymoma

    through study completion, an average of 1.5 years

  • Diagnostic value in thymoma and other masses

    through study completion, an average of 1.5 years

  • CXCR4 expression and SUV

    through study completion, an average of 1.5 years

Study Arms (1)

68Ga-Pentixafor, PET/CT

EXPERIMENTAL

Inject 68Ga-Pentixafor and then perform PET/CT scan.

Drug: 68Ga-Pentixafor

Interventions

Intravenous injection of one dosage of 74-185 MBq(2-5 mCi) 68Ga-Pentixafor. Tracer doses of 68Ga- Pentixafor will be used to image lesions of thymoma by PET/CT.

Also known as: 68Ga-CXCR4
68Ga-Pentixafor, PET/CT

Eligibility Criteria

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

You may qualify if:

  • suspected or confirmed untreated thymoma patients
  • signed written consent.

You may not qualify if:

  • pregnancy
  • breastfeeding
  • known allergy against Pentixafor
  • any medical condition that in the opinion of the investigator,may
  • significantly interfere with study compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospitall, Chinese Academy of Medical Science and Peking Union Medical College

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

  • Gao X, Peng X, Wang R, Qian Z, Zhou X, Zhu Z, Chen Y. An Occult Primary Thymic Mucosa-Associated Lymphoid Tissue Lymphoma With Sjogren's Syndrome Revealed by CXCR4 Targeted 68Ga-Pentixafor PET/CT. J Cell Mol Med. 2025 Feb;29(3):e70248. doi: 10.1111/jcmm.70248.

MeSH Terms

Conditions

Thymoma

Interventions

68Ga-pentixafor

Condition Hierarchy (Ancestors)

Neoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplasmsThymus NeoplasmsThoracic NeoplasmsNeoplasms by SiteLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Zhaohui Zhu

    Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 17, 2023

Study Start

June 22, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

October 17, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations