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CXCR4-targeted PET/CT Imaging in Hematological Malignancies

Sponsor
Zhongnan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05255926
Collaborator
(none)
200
Enrollment
1
Location
1
Arm
25
Anticipated Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
An Exploratory, Open-Label, Single Center Study of CXCR4-targeted PET/CT Imaging for Evaluation of Hematological Malignancies
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity of 68Ga-pentixafor PET/CT for diagnosis and staging in hematological malignancies. [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.

    2. Specificity of 68Ga-pentixafor PET/CT for diagnosis and staging in hematological malignancies. [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.

    3. Accuracy of 68Ga-pentixafor PET/CT for diagnosis and staging in hematological malignancies. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongnan Hospital of Wuhan University Wuhan Hubei China 430071

    Sponsors and Collaborators

    • Zhongnan Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yong He, Principal Investigator, Zhongnan Hospital
    ClinicalTrials.gov Identifier:
    NCT05255926
    Other Study ID Numbers:
    • ZNYYHYXK0002
    First Posted:
    Feb 25, 2022
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Hematologic Neoplasms

    Study Results

    No Results Posted as of Feb 25, 2022