Chemokine Receptor 4 PET/CT Imaging of CXCR4-Related Diseases

NCT ID: NCT06690736

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2027-10-01

Brief Summary

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To evaluate the potential usefulness of 68Ga/18F-Pentixafor/Pentixather positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various CXCR4-related disease patients.

Detailed Description

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Subjects with various CXCR4-related disease patients underwent 68Ga/18F-Pentixafor/Pentixather PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-Pentixafor/Pentixather PET/CT were calculated.

Conditions

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CXCR4-related Disease Tumor Positron Emission Tomography Metastasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CXCR4 PET/CT Imaging

Intravenous injection of one dose of 2-5 mCi 68Ga/18F-Pentixafor/Pentixather. Tracer doses of radiotracers will be used to image lesions by PET/CT

Group Type EXPERIMENTAL

CXCR4 PET/CT Imaging

Intervention Type DIAGNOSTIC_TEST

Each subject receive a single intravenous injection of 68Ga/18F-Pentixafor/Pentixather, and undergo PET/CT imaging within the specificed time.

Interventions

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CXCR4 PET/CT Imaging

Each subject receive a single intravenous injection of 68Ga/18F-Pentixafor/Pentixather, and undergo PET/CT imaging within the specificed time.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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68/18F-Pentixafor 68/18F-Pentixather

Eligibility Criteria

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Inclusion Criteria

* suspected or confirmed untreated Lymphoproliferative and other CXCR4-related diseases patients
* 18F-FDG PET/CT within two weeks
* signed written consent.

Exclusion Criteria

* pregnancy
* breastfeeding
* known allergy against Pentixafor
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Shaobo Yao, PhD

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haonan Yu, MD

Role: CONTACT

+8613821000597

Shaobo Yao, PhD

Role: CONTACT

+8615122570279

Facility Contacts

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Haonan Yu, MD

Role: primary

+8613821000597

Other Identifiers

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TJMUGH-02

Identifier Type: -

Identifier Source: org_study_id

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