18F-Pentixafor PET in Hematologic Malignancies

NCT07122674 | Recruiting

• 1 other identifier: FAHZU-CXCR4-Hemic
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the efficacy of 18F-Pentixafor PET imaging in the diagnosis, staging and response evaluation of hematological malignancies.

Conditions

Hematological Malignancies

Outcome Measures

Primary Outcomes (1)

• Diagnostic efficacy

  Sensitivity, specificity, positive and negative predictive value of 18F-Pentixafor PET/CT and PET/MR Imaging in hematological malignancies.

  through study completion, an average of 1.5 year

Secondary Outcomes (2)

• 18F-Pentixafor PET performence compared with 18F-FDG

  up to 24 months

• Deauville Score

  through study completion, 3-4 years

Study Arms (1)

18F-Pentixafor PET/CT in Hematologic Malignancies

Each patient receive a single intravenous injection of 18F-Pentixafor 55 MBq/kg and undergo PET/CT or PET/MR scan after 60 min post-injection.

Drug: 18F-Pentixafor

Interventions

18F-Pentixafor DRUG

Patients with hematological malignancies receive 55 MBq/kg of 18F-Pentixafor intravenously followed by PET/CT or PET/MR after 60min of injection.

18F-Pentixafor PET/CT in Hematologic Malignancies

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with suspected or confirmed Hematologic Malignancies

You may qualify if:

• Age of 18-80 years old, both sexes, with behavioral capacity;
• patients with suspected or confirmed hematological malignancies;
• F-FDG PET or other imaging examinations should be performed according to the treatment plan;
• For suspected patients, biopsy or needle biopsy is expected to obtain pathological results;
• Can provide informed consent, can understand and comply with the requirements of the study.

You may not qualify if:

• pregnant and lactating women;
• patients with fear or radiophobia, or with mental disorder or primary affective disorder;
• received ionizing radiation outside the scope of this study for clinical medical or scientific research purposes within the past year, resulting in an annual radiation exposure dose exceeding 50 mSv;
• received investigational drugs or devices of uncertain efficacy or safety within 1 month;
• Any condition that the chairpersons of the study consider that any link related to the study may cause harm or have potential harm.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Peipei Wang, MD

CONTACT

86 18511395988; wpp199411@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 14, 2025

Record last verified: 2025-05

Locations

CN (1)