CXCR4-targeted PET/CT for hematologic cancers
An Exploratory, Open-Label, Single Center Study of CXCR4-targeted PET/CT Imaging for Evaluation of Hematological Malignancies
This study will test whether a CXCR4-targeted PET/CT scan (68Ga‑pentixafor) finds and stages blood-cancer lesions better than the standard 18F‑FDG PET/CT in people with newly diagnosed or relapsed hematological malignancies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Zhongnan Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05255926 on ClinicalTrials.gov |
What this trial studies
This is a prospective imaging comparison in patients with newly diagnosed or relapsed hematological malignancies who will undergo both 68Ga‑pentixafor PET/CT and standard 18F‑FDG PET/CT. The scans will be compared for lesion detection, concordance, staging accuracy, and relation to established risk stratification systems. Longitudinal follow-up will link imaging findings to clinical outcomes and prognosis. The protocol also explores deep learning–based image segmentation and other AI techniques to enhance image analysis.
Who should consider this trial
Good fit: Adults aged 18–90 with suspected, newly diagnosed, or relapsed hematological malignancies who can comply with imaging visits and provide informed consent are ideal candidates.
Not a fit: Pregnant or breastfeeding patients, those allergic to the tracer or unable to complete PET/CT (e.g., severe claustrophobia or inability to lie supine), or patients with very high fasting glucose may not benefit or be eligible.
Why it matters
Potential benefit: If successful, CXCR4-targeted PET/CT could improve lesion detection and staging accuracy, leading to more accurate treatment planning for some blood-cancer patients.
How similar studies have performed: Preliminary studies of 68Ga‑pentixafor PET/CT have shown improved lesion detection in several hematologic subtypes, particularly those with low FDG avidity, but larger prospective comparisons remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Volunteer to participate and sign an informed consent form; 2. 18 ≤ Age ≤ 90 years; 3. Patients with highly suspected, or newly diagnosed, or relapsed hematological malignancies; 4. Willing and able to follow schedule visits, treatment plans and laboratory tests. Exclusion Criteria: 1. pregnancy or breastfeeding; 2. Allergic to CXCR4-targeted tracers or excipients; 3. Fasting blood glucose level exceeded 11.0 mmol/L prior to injection of 18F-FDG; 4. Those who cannot complete PET/CT scan, including inability to keep supine, claustrophobia, radiation phobia, etc.; 5. Researchers think it is inappropriate to participate in this clinical trial for patients with poor compliance or other unsuitable factors.
Where this trial is running
Wuhan, Hubei
- Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Yong He, MD, PhD — Zhongnan Hospital
- Study coordinator: Yong He, MD, PhD
- Email: vincentheyong@163.com
- Phone: +86-27-67812698
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.