18F-Pentixafor PET in Hematologic Malignancies

Zhejiang University

Status: Enrolling

Conditions: Hematological Malignancies

Treatments: Drug: 18F-Pentixafor

Study type: Observational

Funder types: Other

Identifiers

NCT07122674

FAHZU-CXCR4-Hemic

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

18F-Pentixafor PET/CT in Hematologic Malignancies

Description:

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.

Treatment:

Drug: 18F-Pentixafor