Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID05255926

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

Led by Zhongnan Hospital · Updated on 2025-06-26

300

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Hematological malignancies are a diverse group of cancers affecting the bone marrow and lymphatic system, often challenging to diagnose and treat due to their varied nature and high mortality. Researchers are evaluating a new imaging method called 68Ga-pentixafor PET/CT, which targets the CXCR4 receptor commonly overexpressed in these cancers. This study aims to compare this method with the standard 18F-FDG PET/CT to improve diagnosis, staging, risk assessment, and prognosis prediction in affected patients. Participants will receive both 68Ga-pentixafor and 18F-FDG PET/CT scans within two weeks. The 68Ga-pentixafor is given intravenously at a dose based on body weight, and imaging is performed one hour after injection. The study also uses artificial intelligence to analyze images, helping detect lesions, measure tumor characteristics, and support personalized treatment decisions. This approach will be explored alongside standard imaging to enhance disease evaluation. During the study, patients will follow scheduled visits, treatments, and laboratory tests. Researchers will assess diagnostic accuracy, staging agreement with clinical systems, and the ability of 68Ga-pentixafor PET/CT to predict progression-free and overall survival over several years. The study includes safety monitoring and aims to develop AI models for risk prediction. Participation may last up to four years with ongoing evaluations to support personalized care.

CONDITIONS

Brief Title

CXCR4-targeted PET/CT Imaging in Hematological Malignancies

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Volunteer to participate and sign an informed consent form
  • Aged 18 to 90 years
  • Patients with suspected, newly diagnosed, or relapsed hematological malignancies
  • Willing and able to follow scheduled visits, treatment plans, and laboratory tests
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Allergy to CXCR4-targeted tracers or their ingredients
  • Fasting blood glucose level above 11.0 mmol/L before 18F-FDG injection
  • Inability to complete PET/CT scans (e.g., cannot lie down, claustrophobia, radiation phobia)
  • Poor compliance or other factors deemed unsuitable by researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Within 2 weeks after screening

Participants undergo both 68Ga-pentixafor and 18F-FDG PET/CT imaging to assess hematological malignancies.

2 imaging visits (in-person)

Long-term Monitoring

Duration - Up to 4 years

Participants are followed over time to evaluate the prognostic relevance of imaging findings and disease progression.

Follow-up visits as scheduled for up to 4 years

Trial Site Locations

Total: 1 location

1

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China, 430071

Actively Recruiting

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Research Team

Y

Yong He, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Frequently Asked Questions

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Published Research Related To This Trial

Chemokine receptor-4 targeted PET/CT with 68Ga-Pentixafor in assessment of newly diagnosed multiple myeloma: comparison to 18F-FDG PET/CT.

Qingqing Pan, Xinxin Cao, Yaping Luo...

https://pubmed.ncbi.nlm.nih.gov/31776631