18F‑Pentixafor PET imaging for blood cancers

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

This will test whether 18F‑Pentixafor PET scans help diagnose, stage, and check treatment response in adults with suspected or confirmed hematologic malignancies.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07122674 on ClinicalTrials.gov

What this trial studies

This observational study uses 18F‑NOTA‑Pentixafor, a PET tracer that binds the CXCR4 receptor, to image patients with suspected or confirmed hematologic malignancies. Participants will receive the tracer and undergo PET imaging about one hour after injection, with image quality and lesion detection compared to standard imaging and available pathology. The study aims to determine whether 18F‑Pentixafor provides better spatial resolution or broader applicability than 18F‑FDG across different blood cancers. Data will include diagnostic performance, staging information, and response evaluation in treated patients.

Who should consider this trial

Good fit: Adults aged 18–80 with suspected or histologically confirmed hematologic malignancies who can provide informed consent and undergo PET imaging and any indicated biopsies.

Not a fit: Patients who are pregnant or breastfeeding, unable to tolerate PET, have had excessive prior radiation exposure, or whose tumors lack CXCR4 expression are unlikely to benefit.

Why it matters

Potential benefit: If successful, this could offer more sensitive and specific PET imaging for a wider range of blood cancers, improving diagnosis, staging, and treatment monitoring.

How similar studies have performed: Related CXCR4‑targeted agents such as 68Ga‑Pentixafor have shown promising results in hematologic cancers, but 18F‑Pentixafor is newer and less extensively tested.

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.

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Peipei Wang, MD

Conditions Hematological Malignancies