Actively Recruiting

Age: 18Years - 80Years
All Genders
ID07122674

Prospective Clinical Study of 18F-Pentixafor PET Imaging in Hematologic Malignancies

Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-08-14

100

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of 18F-Pentixafor PET imaging to improve the diagnosis, staging, and response evaluation of hematological malignancies such as multiple myeloma, leukemia, and lymphoma. This imaging method targets the CXCR-4 receptor, which is overexpressed in these tumors and is linked to tumor growth and poor prognosis. The study aims to assess how well 18F-Pentixafor PET performs compared to current imaging methods like 18F-FDG PET. Participants will receive a single intravenous injection of 18F-Pentixafor at a dose of 55 MBq/kg. After 60 minutes, they will undergo either a PET/CT or PET/MR scan. This process allows for detailed imaging without special preparation. The study includes patients with suspected or confirmed hematological malignancies and involves only one imaging session per participant. During the study, researchers will monitor diagnostic accuracy and compare 18F-Pentixafor PET's performance with traditional 18F-FDG PET imaging. They will also assess disease activity using the Deauville Score over a period of up to 3-4 years. Participants will be involved in imaging procedures and may undergo biopsies if needed for diagnosis. The study will continue until December 2029, with an average follow-up of about 1.5 years for primary outcome assessment.

CONDITIONS

Brief Title

18F-Pentixafor PET in Hematologic Malignancies

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years, any gender, with ability to consent and comply
  • Patients with suspected or confirmed hematological malignancies
  • Have undergone 18F-FDG PET or other imaging as part of treatment plan
  • For suspected cases, biopsy or needle biopsy expected to obtain pathology
  • Able to provide informed consent and understand study requirements
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Patients with fear of radiation, mental disorders, or primary affective disorders
  • Received ionizing radiation exceeding 50 mSv in the past year from other medical or research sources
  • Used investigational drugs or devices with uncertain safety or efficacy within last month
  • Any condition deemed by study leaders to pose potential harm related to study participation

AI-Screening

AI-Powered Screening

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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 - Single day

Participants receive a single intravenous injection of 18F-Pentixafor followed by PET/CT or PET/MR imaging to assess hematological malignancies.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 24 months

Participants are observed for up to 24 months to evaluate diagnostic efficacy and imaging performance over time.

Follow-up visits as per clinical care; visit schedule varies

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310003

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Research Team

P

Peipei Wang, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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