CXCR4-targeted PET/CT Imaging in Hematological Malignancies

November 29, 2022 updated by: Yong He, Zhongnan Hospital

An Exploratory, Open-Label, Single Center Study of CXCR4-targeted PET/CT Imaging for Evaluation of Hematological Malignancies

The incidence and mortality of hematological malignancies remain high. Although 18F-FDG PET/CT imaging is the most common molecular imaging technique used in clinic, the non-specific uptake of 18F-FDG leads to the problems of false negative or positive in hematological malignancies, which makes it difficult to diagnose and evaluate the efficacy. CXCR4 (C-X-C Chemokine Receptor Type 4) is overexpressed in various hematological malignancies, and is associated with poor prognosis. CXCR4-targeted molecular imaging, such as 68Ga-pentixafor PET/CT imaging, has an important potential in hematological malignancies. Therefore, this study will evaluate the efficacy of CXCR4-targeted PET/CT imaging for diagnosis and staging of hematological malignancies, compared with 18F-FDG PET/CT imaging.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
          • Lei Zheng
          • Phone Number: +86-27-67812787
        • Principal Investigator:
          • Yong He, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Volunteer to participate and sign an informed consent form;
  2. 18 ≤ Age ≤ 90 years;
  3. Patients with highly suspected, or newly diagnosed, or relapsed hematological malignancies;
  4. Willing and able to follow schedule visits, treatment plans and laboratory tests.

Exclusion Criteria:

  1. pregnancy or breastfeeding;
  2. Allergic to CXCR4-targeted tracers or excipients;
  3. Fasting blood glucose level exceeded 11.0 mmol/L prior to injection of 18F-FDG;
  4. Those who cannot complete PET/CT scan, including inability to keep supine, claustrophobia, radiation phobia, etc.;
  5. Researchers think it is inappropriate to participate in this clinical trial for patients with poor compliance or other unsuitable factors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-pentixafor and 18F-FDG PET/CT
Investigators recruit patients with highly suspected, or newly diagnosed, or relapsed hematological malignancies. Then patients undergo 68Ga-pentixafor and 18F-FDG PET/CT imaging in one week.
Drug: 68Ga-pentixafor
All participants undergo intravenous administration of 68Ga-pentixafor (1.85-3.71 MBq/kg body weight).
Device: PET/CT
PET/CT imaging is performed 1 h after intravenous injection of 68Ga-pentixafor.
Other Names:
  • Positron Emission Tomography/Computed Tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of 68Ga-pentixafor PET/CT for diagnosis and staging in hematological malignancies.
Time Frame: Two years
For subjects with clinically highly suspected, or newly diagnosed, or relapsed hematological malignancies who undergo 68Ga-pentixafor and 18F-FDG PET/CT imaging in one week. Diagnosis and staging results of 68Ga-pentixafor PET/CT will be compared to 18F-FDG PET/CT imaging, pathology and clinical follow-up results.
Two years
Specificity of 68Ga-pentixafor PET/CT for diagnosis and staging in hematological malignancies.
Time Frame: Two years
For subjects with clinically highly suspected, or newly diagnosed, or relapsed hematological malignancies who undergo 68Ga-pentixafor and 18F-FDG PET/CT imaging in one week. Diagnosis and staging results of 68Ga-pentixafor PET/CT will be compared to 18F-FDG PET/CT imaging, pathology and clinical follow-up results.
Two years
Accuracy of 68Ga-pentixafor PET/CT for diagnosis and staging in hematological malignancies.
Time Frame: Two years
Taking the pathology or clinical follow-up as gold standard, the probability of accurate diagnosis and staging (including true positive and true negative) for 68Ga-pentixafor PET/CT imaging will be calculated in subjects with clinically highly suspected, or newly diagnosed, or relapsed hematological malignancies. The result will be compared to 18F-FDG PET/CT imaging.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongnan Hospital

Investigators

  • Principal Investigator: Yong He, MD, PhD, Zhongnan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

March 31, 2024

Study Completion (Anticipated)

March 31, 2024

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

February 15, 2022

First Posted (Actual)

February 25, 2022

Study Record Updates

Last Update Posted (Actual)

December 1, 2022

Last Update Submitted That Met QC Criteria

November 29, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZNYYHYXK0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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