NCT06690736

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Mar 2022

Longer than P75 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 Progress75%
Mar 2022Oct 2027

Study Start

First participant enrolled

March 1, 2022

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

5.6 years

First QC Date

November 13, 2024

Last Update Submit

February 7, 2025

Conditions

CXCR4-related DiseaseTumorPositron Emission TomographyMetastasis

Keywords

PET/CTChemokine receptor 4PentixaforPentixather

Outcome Measures

Primary Outcomes (1)

  • Standardized uptake value (SUV)

    Standardized uptake value (SUV) of FAPI for each target lesion of subject or suspected primary tumor or/and metastasis.

    30 days

Secondary Outcomes (1)

  • Diagnostic efficacy

    30 days

Study Arms (1)

CXCR4 PET/CT Imaging

EXPERIMENTAL

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

Diagnostic Test: CXCR4 PET/CT Imaging

Interventions

CXCR4 PET/CT ImagingDIAGNOSTIC_TEST

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

Also known as: 68/18F-Pentixafor, 68/18F-Pentixather
CXCR4 PET/CT Imaging

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pregnancy
  • breastfeeding
  • known allergy against Pentixafor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

MeSH Terms

Conditions

NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Haonan Yu, MD

CONTACT

+8613821000597dreamadam@126.com

Shaobo Yao, PhD

CONTACT

+8615122570279yaoshaobo008@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
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

November 13, 2024

First Posted

November 15, 2024

Study Start

March 1, 2022

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

February 11, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)