CXCR4NCT05255926
CXCR4-targeted PET/CT Imaging in Hematological Malignancies
A study testing 68Ga-pentixafor and PET/CT in people with CXCR4 and PET/CT, run by Zhongnan Hospital at 1 site in China.
Trial summary
Hematological malignancies continue to pose significant clinical challenges due to their high incidence, heterogeneous biology, and substantial mortality. Although 18F-FDG PET/CT remains the most commonly used molecular imaging modality, its limited specificity can result in false-positive or false-negative findings… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- CXCR4, PET/CT, Hematological Malignancy
- What is being tested?
- 68Ga-pentixafor and PET/CT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer to participate and sign an informed consent form;
- 18 ≤ Age ≤ 90 years;
- Patients with highly suspected, or newly diagnosed, or relapsed hematological malignancies;
- Willing and able to follow schedule visits, treatment plans and laboratory tests.
Who cannot join
- pregnancy or breastfeeding;
- Allergic to CXCR4-targeted tracers or excipients;
- Fasting blood glucose level exceeded 11.0 mmol/L prior to injection of 18F-FDG;
- Those who cannot complete PET/CT scan, including inability to keep supine, claustrophobia, radiation phobia, etc.;
- Researchers think it is inappropriate to participate in this clinical trial for patients with poor compliance or other unsuitable factors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Lei Zheng, +86-27-67812787
Yong He, MD, PhD
About this study
Official title: An Exploratory, Open-Label, Single Center Study of CXCR4-targeted PET/CT Imaging for Evaluation of Hematological Malignancies
Hematological malignancies continue to pose significant clinical challenges due to their high incidence, heterogeneous biology, and substantial mortality. Although 18F-FDG PET/CT remains the most commonly used molecular imaging modality, its limited specificity can result in false-positive or false-negative findings, especially in indolent or low-metabolism subtypes, thereby hampering accurate diagnosis, staging, and therapeutic evaluation. C-X-C chemokine receptor type 4 (CXCR4) is frequently overexpressed in a broad spectrum of hematologic malignancies and correlates with aggressive disease and unfavorable outcomes. CXCR4-targeted molecular imaging using ^68Ga-pentixafor PET/CT has shown promise for improved disease characterization. This prospective study aims to systematically compare 68Ga-pentixafor PET/CT with 18F-FDG PET/CT in terms of diagnostic performance, staging accuracy, risk stratification, and prognostic relevance in patients with hematological malignancies. Furthermore, the study will incorporate artificial intelligence-based image analysis to enhance lesion detection, automate quantitative assessments, and support personalized clinical decision-making.
Read the detailed description
Hematological malignancies encompass a heterogeneous group of neoplasms originating from the bone marrow and lymphatic system. Despite advances in therapeutic strategies, the prognosis for many subtypes remains suboptimal, and accurate initial evaluation is critical for appropriate treatment planning. ^18F-FDG PET/CT is routinely used for functional imaging in these patients; however, its diagnostic utility is limited by variable glucose metabolism across disease subtypes and inflammatory uptake, which can lead to misclassification.
CXCR4, a chemokine receptor involved in tumor proliferation, invasion, and microenvironmental interactions, is overexpressed in numerous hematologic malignancies and has emerged as a molecular target for both imaging and therapy. 68Ga-pentixafor, a CXCR4-targeted PET radiotracer, has demonstrated superior lesion detection in preliminary studies, particularly in diseases with low 18F-FDG avidity.
This prospective study will investigate the clinical utility of 68Ga-pentixafor PET/CT in patients with newly diagnosed or relapsed hematological malignancies. Comparative analyses with 18F-FDG PET/CT will be performed to assess concordance, staging accuracy, and association with known risk stratification systems. Longitudinal follow-up will be conducted to evaluate the prognostic relevance of imaging findings.
In parallel, the study will explore the application of artificial intelligence (AI) techniques, including deep learning-based image segmentation and radiomic feature extraction, to enhance diagnostic precision and support risk-adapted management strategies. AI-driven models will be developed and validated to predict disease burden, progression, and survival, thereby contributing to personalized medicine in hematologic oncology.
- Conditions
- CXCR4, PET/CT, Hematological Malignancy
- Being tested
- 68Ga-pentixafor, PET/CT
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-pentixaforDrug
All participants undergo intravenous administration of 68Ga-pentixafor (1.85-3.71 MBq/kg body weight).
PET/CTDevice
Also called Positron Emission Tomography/Computed Tomography
PET/CT imaging is performed 1 h after intravenous injection of 68Ga-pentixafor.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-pentixafor and 18F-FDG PET/CT | Experimental | Patients with a high clinical suspicion of, or confirmed newly diagnosed or relapsed hematological malignancies will be recruited. All enrolled patients will undergo both 68Ga-pentixafor and 18F-FDG PET/CT imaging within two weeks. Receives: Drug: 68Ga-pentixafor; Device: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of 68Ga-pentixafor PET/CT Compared to 18F-FDG PET/CT in Hematological Malignancies
To assess and compare the diagnostic accuracy of 68Ga-pentixafor PET/CT and 18F-FDG PET/CT in patients with newly diagnosed, relapsed, or highly suspected hematological malignancies. Accuracy will be evaluated using a composite reference standard, including histopathological confirmation, clinical follow-up, and additional imaging findings.
Measured: Two years
Concordance of [⁶⁸Ga]Ga-pentixafor PET/CT with Standard Clinical Staging Systems
To evaluate the concordance between [⁶⁸Ga]Ga-pentixafor PET/CT-based staging and conventional clinical staging systems (e.g., Ann Arbor, Durie-Salmon PLUS, R-ISS/R2-ISS) in patients with hematological malignancies. Concordance will be measured using Cohen's kappa statistic (κ).
Measured: Two years
Predictive Value of [⁶⁸Ga]Ga-pentixafor PET/CT Parameters for Progression-Free Survival
To assess whether imaging biomarkers from [⁶⁸Ga]Ga-pentixafor PET/CT, such as SUVmax or total lesion CXCR4 uptake, predict progression-free survival (PFS) in patients with hematological malignancies. Comparison will be made with [¹⁸F]FDG PET/CT-derived parameters.
Measured: Four years
Predictive Value of [⁶⁸Ga]Ga-pentixafor PET/CT Parameters for Overall Survival
To evaluate whether [⁶⁸Ga]Ga-pentixafor PET/CT-based biomarkers can predict overall survival in patients with hematological malignancies, compared with [¹⁸F]FDG PET/CT.
Measured: Four years
Dice Similarity Coefficient (DSC) for AI-based lesion segmentation
Evaluation of the overlap between artificial intelligence-generated lesion segmentations and expert manual annotations on PET/CT images using the Dice similarity coefficient (DSC).
Measured: Two years
Secondary outcomes (3)
Correlation Between CXCR4 Expression and [⁶⁸Ga]Ga-pentixafor PET/CT Parameters
To assess the correlation between CXCR4 expression levels in biopsy samples and semiquantitative parameters from [⁶⁸Ga]Ga-pentixafor PET/CT (e.g., SUVmax).
Measured: Two years
Correlation between del(17p) status and TLU on [68Ga]Ga-pentixafor PET/CT
To assess the correlation between the presence or absence of del(17p), as identified by fluorescence in situ hybridization (FISH), and total lesion uptake (TLU) on [68Ga]Ga-pentixafor PET/CT at baseline. The degree of correlation will be measured using the Spearman correlation coefficient (rho), a unitless value ranging from -1 to +1.
Measured: Two years
Radiogenomic Model for Risk Prediction Using AI
To develop and validate an AI-based radiogenomic model integrating PET imaging features and genomic data to predict disease aggressiveness in patients with hematological malignancies.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 Mar 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CXCR4Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong He, Zhongnan Hospital
- Investigators
- Yong He, MD, PhD, Principal investigator, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255926
- Sponsor's protocol ID
- ZNYYHYXK0002
- Status last verified
- Jun 2025
- First submitted
- 26 Jan 2022
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herrmann K, Lapa C, Wester HJ, Schottelius M, Schiepers C, Eberlein U, Bluemel C, Keller U, Knop S, Kropf S, Schirbel A, Buck AK, Lassmann M. Biodistribution and radiation dosimetry for the chemokine receptor CXCR4-targeting probe 68Ga-pentixafor. J Nucl Med. 2015 Mar;56(3):410-6. doi: 10.2967/jnumed.114.151647. Epub 2015 Feb 19.
PubMed 25698782Pan Q, Cao X, Luo Y, Li J, Feng J, Li F. Chemokine receptor-4 targeted PET/CT with 68Ga-Pentixafor in assessment of newly diagnosed multiple myeloma: comparison to 18F-FDG PET/CT. Eur J Nucl Med Mol Imaging. 2020 Mar;47(3):537-546. doi: 10.1007/s00259-019-04605-z. Epub 2019 Nov 27.
PubMed 31776631Duell J, Krummenast F, Schirbel A, Klassen P, Samnick S, Rauert-Wunderlich H, Rasche L, Buck AK, Wester HJ, Rosenwald A, Einsele H, Topp MS, Lapa C, Kircher M. Improved Primary Staging of Marginal-Zone Lymphoma by Addition of CXCR4-Directed PET/CT. J Nucl Med. 2021 Oct;62(10):1415-1421. doi: 10.2967/jnumed.120.257279. Epub 2021 Feb 12.
PubMed 33579803Chen J, Tang S, Liu L, Tian Y, Wang Y, Xiao Z, Xing D, Zhou F, Li C, He Y. [68Ga]Ga-Pentixafor PET/CT for Durie-Salmon PLUS staging and risk stratification in newly diagnosed multiple myeloma. Eur J Nucl Med Mol Imaging. 2026 Jun;53(7):4572-4586. doi: 10.1007/s00259-026-07813-6. Epub 2026 Feb 28.
PubMed 41760826
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Open-Label, Single Center Study of CXCR4-targeted PET/CT Imaging for Evaluation of Hematological Malignancies
- ClinicalTrials.gov ID
- NCT05255926
- Acronym / sponsor ID
- ZNYYHYXK0002
- Conditions
- CXCR4, PET/CT, Hematological Malignancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hematological malignancies continue to pose significant clinical challenges due to their high incidence, heterogeneous biology, and substantial mortality. Although 18F-FDG PET/CT remains the most commonly used molecular imaging modality, its limited specificity can result in false-positive or false-negative findings, especially in indolent or low-metabolism subtypes, thereby hampering accurate diagnosis, staging, and therapeutic evaluation. C-X-C chemokine receptor type 4 (CXCR4) is frequently overexpressed in a broad spectrum of hematologic malignancies and correlates with aggressive disease and unfavorable outcomes. CXCR4-targeted molecular imaging using ^68Ga-pentixafor PET/CT has shown promise for improved disease characterization. This prospective study aims to systematically compare 68Ga-pentixafor PET/CT with 18F-FDG PET/CT in terms of diagnostic performance, staging accuracy, risk stratification, and prognostic relevance in patients with hematological malignancies. Furthermore, the study will incorporate artificial intelligence-based image analysis to enhance lesion detection, automate quantitative assessments, and support personalized clinical decision-making.
Detailed description
Hematological malignancies encompass a heterogeneous group of neoplasms originating from the bone marrow and lymphatic system. Despite advances in therapeutic strategies, the prognosis for many subtypes remains suboptimal, and accurate initial evaluation is critical for appropriate treatment planning. ^18F-FDG PET/CT is routinely used for functional imaging in these patients; however, its diagnostic utility is limited by variable glucose metabolism across disease subtypes and inflammatory uptake, which can lead to misclassification.
CXCR4, a chemokine receptor involved in tumor proliferation, invasion, and microenvironmental interactions, is overexpressed in numerous hematologic malignancies and has emerged as a molecular target for both imaging and therapy. 68Ga-pentixafor, a CXCR4-targeted PET radiotracer, has demonstrated superior lesion detection in preliminary studies, particularly in diseases with low 18F-FDG avidity.
This prospective study will investigate the clinical utility of 68Ga-pentixafor PET/CT in patients with newly diagnosed or relapsed hematological malignancies. Comparative analyses with 18F-FDG PET/CT will be performed to assess concordance, staging accuracy, and association with known risk stratification systems. Longitudinal follow-up will be conducted to evaluate the prognostic relevance of imaging findings.
In parallel, the study will explore the application of artificial intelligence (AI) techniques, including deep learning-based image segmentation and radiomic feature extraction, to enhance diagnostic precision and support risk-adapted management strategies. AI-driven models will be developed and validated to predict disease burden, progression, and survival, thereby contributing to personalized medicine in hematologic oncology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-pentixafor and 18F-FDG PET/CT | Experimental | Drug: 68Ga-pentixafor, Device: PET/CTPatients with a high clinical suspicion of, or confirmed newly diagnosed or relapsed hematological malignancies will be recruited. All enrolled patients will undergo both 68Ga-pentixafor and 18F-FDG PET/CT imaging within two weeks. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteer to participate and sign an informed consent form;
- 18 ≤ Age ≤ 90 years;
- Patients with highly suspected, or newly diagnosed, or relapsed hematological malignancies;
- Willing and able to follow schedule visits, treatment plans and laboratory tests.
Key exclusion criteria (5 listed)
- pregnancy or breastfeeding;
- Allergic to CXCR4-targeted tracers or excipients;
- Fasting blood glucose level exceeded 11.0 mmol/L prior to injection of 18F-FDG;
- Those who cannot complete PET/CT scan, including inability to keep supine, claustrophobia, radiation phobia, etc.;
- Researchers think it is inappropriate to participate in this clinical trial for patients with poor compliance or other unsuitable factors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-pentixaforAll participants undergo intravenous administration of 68Ga-pentixafor (1.85-3.71 MBq/kg body weight). | Drug | 68Ga-pentixafor and 18F-FDG PET/CT |
| PET/CTAlso: Positron Emission Tomography/Computed TomographyPET/CT imaging is performed 1 h after intravenous injection of 68Ga-pentixafor. | Device | 68Ga-pentixafor and 18F-FDG PET/CT |
Primary outcome
Diagnostic Accuracy of 68Ga-pentixafor PET/CT Compared to 18F-FDG PET/CT in Hematological Malignancies
Time frame: Two years
To assess and compare the diagnostic accuracy of 68Ga-pentixafor PET/CT and 18F-FDG PET/CT in patients with newly diagnosed, relapsed, or highly suspected hematological malignancies. Accuracy will be evaluated using a composite reference standard, including histopathological confirmation, clinical follow-up, and additional imaging findings.
Concordance of [⁶⁸Ga]Ga-pentixafor PET/CT with Standard Clinical Staging Systems
Time frame: Two years
To evaluate the concordance between [⁶⁸Ga]Ga-pentixafor PET/CT-based staging and conventional clinical staging systems (e.g., Ann Arbor, Durie-Salmon PLUS, R-ISS/R2-ISS) in patients with hematological malignancies. Concordance will be measured using Cohen's kappa statistic (κ).
Predictive Value of [⁶⁸Ga]Ga-pentixafor PET/CT Parameters for Progression-Free Survival
Time frame: Four years
To assess whether imaging biomarkers from [⁶⁸Ga]Ga-pentixafor PET/CT, such as SUVmax or total lesion CXCR4 uptake, predict progression-free survival (PFS) in patients with hematological malignancies. Comparison will be made with [¹⁸F]FDG PET/CT-derived parameters.
Predictive Value of [⁶⁸Ga]Ga-pentixafor PET/CT Parameters for Overall Survival
Time frame: Four years
To evaluate whether [⁶⁸Ga]Ga-pentixafor PET/CT-based biomarkers can predict overall survival in patients with hematological malignancies, compared with [¹⁸F]FDG PET/CT.
Dice Similarity Coefficient (DSC) for AI-based lesion segmentation
Time frame: Two years
Evaluation of the overlap between artificial intelligence-generated lesion segmentations and expert manual annotations on PET/CT images using the Dice similarity coefficient (DSC).
3 secondary outcomes
Correlation Between CXCR4 Expression and [⁶⁸Ga]Ga-pentixafor PET/CT Parameters
Time frame: Two years
Correlation between del(17p) status and TLU on [68Ga]Ga-pentixafor PET/CT
Time frame: Two years
Radiogenomic Model for Risk Prediction Using AI
Time frame: Two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Background: PubMed 25698782Herrmann K, Lapa C, Wester HJ, Schottelius M, Schiepers C, Eberlein U, Bluemel C, Keller U, Knop S, Kropf S, Schirbel A, Buck AK, Lassmann M. Biodistribution and radiation dosimetry for the chemokine receptor CXCR4-targeting probe 68Ga-pentixafor. J Nucl Med. 2015 Mar;56(3):410-6. doi: 10.2967/jnumed.114.151647. Epub 2015 Feb 19.
- Background: PubMed 31776631Pan Q, Cao X, Luo Y, Li J, Feng J, Li F. Chemokine receptor-4 targeted PET/CT with 68Ga-Pentixafor in assessment of newly diagnosed multiple myeloma: comparison to 18F-FDG PET/CT. Eur J Nucl Med Mol Imaging. 2020 Mar;47(3):537-546. doi: 10.1007/s00259-019-04605-z. Epub 2019 Nov 27.
- Background: PubMed 33579803Duell J, Krummenast F, Schirbel A, Klassen P, Samnick S, Rauert-Wunderlich H, Rasche L, Buck AK, Wester HJ, Rosenwald A, Einsele H, Topp MS, Lapa C, Kircher M. Improved Primary Staging of Marginal-Zone Lymphoma by Addition of CXCR4-Directed PET/CT. J Nucl Med. 2021 Oct;62(10):1415-1421. doi: 10.2967/jnumed.120.257279. Epub 2021 Feb 12.
- Derived from this study: PubMed 41760826Chen J, Tang S, Liu L, Tian Y, Wang Y, Xiao Z, Xing D, Zhou F, Li C, He Y. [68Ga]Ga-Pentixafor PET/CT for Durie-Salmon PLUS staging and risk stratification in newly diagnosed multiple myeloma. Eur J Nucl Med Mol Imaging. 2026 Jun;53(7):4572-4586. doi: 10.1007/s00259-026-07813-6. Epub 2026 Feb 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yong He, MD, PhD principal investigator
Zhongnan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-pentixafor and PET/CT in people with CXCR4 and PET/CT, run by Zhongnan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong He, MD, PhD (+86-27-67812698, vincentheyong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of 68Ga-pentixafor PET/CT Compared to 18F-FDG PET/CT in Hematological Malignancies (time frame: Two years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05255926, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.