18F-Pentixafor PET in Hematologic Malignancies

NCT ID: NCT07122674

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2029-12-31

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.

Detailed Description

18F-FDG PET imaging based on the principle of glucose metabolism imaging is currently dominant in the staging and efficacy evaluation of lymphoma, but it is not suitable for a wider range of hematological tumors. Chemokine receptor 4 (CXCR-4) is a G protein-coupled receptor, which is overexpressed in a variety of hematological malignancies (MM, leukemia, lymphoma, etc.). It promotes tumor growth, invasion, metastasis, drug resistance, immune escape, and is associated with poor prognosis of tumors. 18Fluorine18 (18F)-NOTA-Pentixafor (18f-pentixafor) is a novel specific molecular probe targeting CXCR-4. Compared with 68Ga-Pentixafor, 18f-pentixafor has a longer half-life. More patients can be used in one synthesis, and the image quality is better and the spatial resolution is higher. Patients can undergo PET at 1 h after injection without special preparation. The aim of this study is to evaluate the performance of 18F-Pentixafor PET imaging in the diagnosis, staging, and response evaluation of hematological malignancies. Patients with suspected or histologically confirmed hematological malignancies will be enrolled in this study.

Conditions

Hematological Malignancies

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

18F-Pentixafor

Intervention Type: DRUG

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

Interventions

18F-Pentixafor

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age of 18-80 years old, both sexes, with behavioral capacity;

2. patients with suspected or confirmed hematological malignancies;

3. 18F-FDG PET or other imaging examinations should be performed according to the treatment plan;

4. For suspected patients, biopsy or needle biopsy is expected to obtain pathological results;

5. Can provide informed consent, can understand and comply with the requirements of the study.

Exclusion Criteria

1. pregnant and lactating women;

2. patients with fear or radiophobia, or with mental disorder or primary affective disorder;

3. 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;

4. received investigational drugs or devices of uncertain efficacy or safety within 1 month;

5. Any condition that the chairpersons of the study consider that any link related to the study may cause harm or have potential harm.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Peipei Wang, MD

Role: CONTACT

wpp199411@163.com

86 18511395988

Facility Contacts

Xinhui Su, MD

Role: primary

suxinhui@zju.edu.cn

86 13806071262

Peipei Wang, MD

Role: backup

wpp199411@163.com

86 18511395988

Other Identifiers

FAHZU-CXCR4-Hemic

Identifier Type: -

Identifier Source: org_study_id