CXCR4-targeted PET/CT for hematologic cancers
Official title: An Exploratory, Open-Label, Single Center Study of CXCR4-targeted PET/CT Imaging for Evaluation of Hematological Malignancies
Run by Zhongnan Hospital · NCT05255926 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Zhongnan Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Wuhan, Hubei) |
| Status | Recruiting |
| Started | March 1, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | June 26, 2025 |
| Trial ID | NCT05255926 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.