18F-Pentixafor PET in Hematologic Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F-Pentixafor.
- Who it may be relevant to
- Registry conditions: Hematological Malignancies. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Clinical Study of 18F-Pentixafor PET Imaging in Hematologic Malignancies
Overview
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.
Interventions
- Drug 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.
Primary outcome measures
- Diagnostic efficacy [Time frame: through study completion, an average of 1.5 year]
Secondary outcome measures (2)
- 18F-Pentixafor PET performence compared with 18F-FDG [Time frame: up to 24 months]
- Deauville Score [Time frame: through study completion, 3-4 years]
Eligibility criteria
Inclusion criteria
- Age of 18-80 years old, both sexes, with behavioral capacity;
- patients with suspected or confirmed hematological malignancies;
- 18F-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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT07122674 · FAHZU-CXCR4-Hemic