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Application of 68Ga-Pentixafor PET/CT for Thymoma

Primary Purpose

Thymoma

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-Pentixafor
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thymoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: suspected or confirmed untreated thymoma patients signed written consent. Exclusion Criteria: pregnancy breastfeeding known allergy against Pentixafor any medical condition that in the opinion of the investigator,may significantly interfere with study compliance.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-Pentixafor, PET/CT

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Diagnostic value
Diagnostic value of 68Ga-Pentixafor PET/CT for thymoma in comparison with 18F-FDG PET/CT or CT or MRI.
Diagnostic value in special type of thymoma
Diagnostic value of 68Ga-Pentixafor PET/CT in special type thymoma (A\AB\B\C subtypes)
Diagnostic value in thymoma and other masses
Diagnostic value of 68Ga-Pentixafor PET/CT in thymoma and other anterior mediastinal mass.
CXCR4 expression and SUV
Correlation between CXCR4 expression and SUV in PET

Full Information

First Posted
October 11, 2023
Last Updated
October 11, 2023
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06086327
Brief Title
Application of 68Ga-Pentixafor PET/CT for Thymoma
Official Title
Chemokine Receptor CXCR4-targeting PET Imaging for Thymoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Thymoma is 1 rare type of tumor developed on the thymic epithelium; patients with thymoma also might have myasthenia gravis (MG). Because of the scarcity and complexity of MG-associated thymoma, its pathogenesis and etiology still remain unclear nowadays. The expression of C-X-C chemokine receptor type 4 (CXCR4) is absent or low in most healthy tissues but highly expressed in various types of tumors. CXCR4 might contribute to the clinical cancer progression, and CXCR4 could be a valuable prognostic biomarker in the therapy of MG-associated thymoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-Pentixafor, PET/CT
Arm Type
Experimental
Arm Description
Inject 68Ga-Pentixafor and then perform PET/CT scan.
Intervention Type
Drug
Intervention Name(s)
68Ga-Pentixafor
Other Intervention Name(s)
68Ga-CXCR4
Intervention Description
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.
Primary Outcome Measure Information:
Title
SUVmax and SUVmean
Description
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.
Time Frame
through study completion, an average of 1.5 years
Secondary Outcome Measure Information:
Title
Diagnostic value
Description
Diagnostic value of 68Ga-Pentixafor PET/CT for thymoma in comparison with 18F-FDG PET/CT or CT or MRI.
Time Frame
through study completion, an average of 1.5 years
Title
Diagnostic value in special type of thymoma
Description
Diagnostic value of 68Ga-Pentixafor PET/CT in special type thymoma (A\AB\B\C subtypes)
Time Frame
through study completion, an average of 1.5 years
Title
Diagnostic value in thymoma and other masses
Description
Diagnostic value of 68Ga-Pentixafor PET/CT in thymoma and other anterior mediastinal mass.
Time Frame
through study completion, an average of 1.5 years
Title
CXCR4 expression and SUV
Description
Correlation between CXCR4 expression and SUV in PET
Time Frame
through study completion, an average of 1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: suspected or confirmed untreated thymoma patients signed written consent. Exclusion Criteria: pregnancy breastfeeding known allergy against Pentixafor any medical condition that in the opinion of the investigator,may significantly interfere with study compliance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rongxi Wang
Phone
+8615584172170
Email
zhzwrx.123@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaohui Zhu
Phone
+8613611093752
Email
13611093752@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu
Organizational Affiliation
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospitall, Chinese Academy of Medical Science and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, MD
Phone
+8613611093752
Email
13611093752@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Application of 68Ga-Pentixafor PET/CT for Thymoma

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