LymphomaEarly Phase 1NCT04504526
Value of Chemokine Receptor CXCR4 Imaging for Diagnosis and Prognostic Evaluation in Lymphoproliferative Diseases
A Early Phase 1 study testing 68Ga-Pentixafor in people with Lymphoma and Multiple Myeloma, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
Chemokine receptor CXCR4 is normally expressed on T-lymphocytes, B-lymphocytes, monocytes, macrophages, neutrophils and eosinophils as well as hematopoietic stem and progenitor cells (HSPC) in the bone marrow. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lymphoma, Multiple Myeloma, Leukemia
- What is being tested?
- 68Ga-Pentixafor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2020to 31 Dec 2027
- Phase
- Early Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suspected or confirmed untreated Lymphoproliferative diseases patients
- 18F-FDG PET/CT within two weeks
- signed written consent.
Who cannot join
- pregnancy
- breastfeeding
- known allergy against Pentixafor
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
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Weibing Miao, MD, +86 591 87981618, miaoweibing@126.com
Zhenying Chen, MB, +86 591 87981619, 714144972@qq.com
About this study
Official title: Value of Chemokine Receptor CXCR4-targeting Molecular Imaging for Diagnosis and Prognostic Evaluation in Lymphoproliferative Diseases
Chemokine receptor CXCR4 is normally expressed on T-lymphocytes, B-lymphocytes, monocytes, macrophages, neutrophils and eosinophils as well as hematopoietic stem and progenitor cells (HSPC) in the bone marrow. 68Ga-Pentixafor PET/CT represents a promising method for the in vivo assessment of the CXCR4 expression status in cancer patients, especially in hematologic malignancies. This prospective study is going to investigate whether metabolic characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, risk stratification, and the prognostic evaluation in lymphoproliferative diseases.
Read the detailed description
Lymphoma:
The marginal zone lymphoma, plasma cell lymphoma, T-cell-lymphoma frequently do not present with an elevated FDG uptake. However, lymphoma is a frequent cancer with high CXCR4 expression. The previous studies showed 68Ga-pentixafor-PET seems to be a highly selective and specific method for the in vivo quantification of CXCR4 expression. Thus, our study is going to investigate the value of 68Ga-pentixafor-PET/CT for the diagnosis and prognostic evaluation of CXCR4 expression in lymphoma.
Multiple myeloma:
Multiple myeloma (MM) is characterized by the neoplastic proliferation of plasma cells producing a monoclonal immunoglobulin. Minimal residual disease (MRD) status is an important predictor of clinical outcome in MM. But it is difficult to assess the accurate MRD status because of the significant heterogeneity characterizing with 18F-FDG PET/CT. Studies showed Chemokine receptor CXCR4 was expressed in MM cells and CXCR4-targeting molecular imaging-68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of MM with higher accuracy. This prospective study is going to investigate the value of 68Ga-Pentixafor PET/CT for the diagnosis and prognostic evaluation of CXCR4 expression in MM.
Leukemia： Leukemia is the second largest family of hematological malignancies after the lymphomas, and, depending on the subtype, may show a considerable overlap of histological features with the latter. The four main kinds of leukemia are, in the order of their prevalence. Imaging has traditionally played a limited role in the work-up of leukemias, with regard to detection, staging, and response assessment. 18F-FDG PET/CT is not recommended for routine evaluation of CLL, because the disease shows low uptake in the majority of cases. Although, the clinical utility of MRI lies in the detection of bone marrow abnormalities that are suspicious for leukemia in adult and pediatric patients with unclear musculoskeletal symptoms with its reduced radiation dose (in comparison with PET/CT). However, it may become more attractive with the use of newer, non-FDG PET radiotracers. High CXCR4 expression is known to be associated with poor prognosis in CLL. Recently, the feasibility of 68Ga-Pentixafor PET has also been demonstrated for CLL and AML. This prospective study is going to investigate the value of 68Ga-Pentixafor PET/CT for the diagnosis and prognostic evaluation of CXCR4 expression in leukemia.
- Conditions
- Lymphoma, Multiple Myeloma, Leukemia
- Being tested
- 68Ga-Pentixafor
- Medical subject headings
- Lymphoma, Multiple Myeloma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-PentixaforDrug
Intravenous injection of one dose of 74-148 MBq (2-4 mCi) 68Ga-Pentixafor. Tracer doses of 68Ga- Pentixafor will be used to image lesions by PET/CT.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-Pentixafor, PET/CT | Experimental | PET/CT perform after injecting 68Ga-Pentixafor Receives: Drug: 68Ga-Pentixafor |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmax
SUVmax of focal lesions are measured on 68Ga-Pentixafor PET/CT. The SUVmax of the liver, and/or mediastinal blood pool, and/or L3 vertebra are defined as the background.
Measured: through study completion, an average of 3 years
The time for patient's survival
Investigators follow up and record the time for patient's survival. To investigate the ralationship between initial SUVmax of focal lesions and survival. Finally, the prognostic evaluation of 68Ga-Pentixafor PET/CT for lymphoproliferative diseases in comparison with 18F-FDG PET/CT.
Measured: through study completion, an average of 3 years
Secondary outcomes (1)
Diagnostic sensitivity and specficity in special type of lymphoma
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start7 Aug 2020
- Primary completionDec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weibing Miao, PhD, First Affiliated Hospital of Fujian Medical University
- Investigators
- Weibing Miao, M.D., Principal investigator, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504526
- Sponsor's protocol ID
- FirstAHFMUCXCR4
- Status last verified
- Jul 2026
- First submitted
- 1 Aug 2020
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pan Q, Chen Z, Liu S, Zhang H, Feng J, Miao W, Li F, Cao X, Luo Y. Reduced splenic uptake of [68Ga]Ga-Pentixafor following first-line chemotherapy is associated with poor prognosis in patients with newly diagnosed multiple myeloma. EJNMMI Res. 2025 Jun 20;15(1):74. doi: 10.1186/s13550-025-01262-2.
PubMed 40540129Chen Z, Yang A, Zhang J, Chen A, Zhang Y, Huang C, Chen S, Yao S, Miao W. CXCR4-Directed PET/CT with [68Ga]Pentixafor in Central Nervous System Lymphoma: A Comparison with [18F]FDG PET/CT. Mol Imaging Biol. 2022 Jun;24(3):416-424. doi: 10.1007/s11307-021-01664-3. Epub 2021 Oct 14.
PubMed 34651291
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Chemokine Receptor CXCR4-targeting Molecular Imaging for Diagnosis and Prognostic Evaluation in Lymphoproliferative Diseases
- ClinicalTrials.gov ID
- NCT04504526
- Acronym / sponsor ID
- FirstAHFMUCXCR4
- Conditions
- Lymphoma, Multiple Myeloma, Leukemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Aug 2020 (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.
Chemokine receptor CXCR4 is normally expressed on T-lymphocytes, B-lymphocytes, monocytes, macrophages, neutrophils and eosinophils as well as hematopoietic stem and progenitor cells (HSPC) in the bone marrow. 68Ga-Pentixafor PET/CT represents a promising method for the in vivo assessment of the CXCR4 expression status in cancer patients, especially in hematologic malignancies. This prospective study is going to investigate whether metabolic characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, risk stratification, and the prognostic evaluation in lymphoproliferative diseases.
Detailed description
Lymphoma:
The marginal zone lymphoma, plasma cell lymphoma, T-cell-lymphoma frequently do not present with an elevated FDG uptake. However, lymphoma is a frequent cancer with high CXCR4 expression. The previous studies showed 68Ga-pentixafor-PET seems to be a highly selective and specific method for the in vivo quantification of CXCR4 expression. Thus, our study is going to investigate the value of 68Ga-pentixafor-PET/CT for the diagnosis and prognostic evaluation of CXCR4 expression in lymphoma.
Multiple myeloma:
Multiple myeloma (MM) is characterized by the neoplastic proliferation of plasma cells producing a monoclonal immunoglobulin. Minimal residual disease (MRD) status is an important predictor of clinical outcome in MM. But it is difficult to assess the accurate MRD status because of the significant heterogeneity characterizing with 18F-FDG PET/CT. Studies showed Chemokine receptor CXCR4 was expressed in MM cells and CXCR4-targeting molecular imaging-68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of MM with higher accuracy. This prospective study is going to investigate the value of 68Ga-Pentixafor PET/CT for the diagnosis and prognostic evaluation of CXCR4 expression in MM.
Leukemia： Leukemia is the second largest family of hematological malignancies after the lymphomas, and, depending on the subtype, may show a considerable overlap of histological features with the latter. The four main kinds of leukemia are, in the order of their prevalence. Imaging has traditionally played a limited role in the work-up of leukemias, with regard to detection, staging, and response assessment. 18F-FDG PET/CT is not recommended for routine evaluation of CLL, because the disease shows low uptake in the majority of cases. Although, the clinical utility of MRI lies in the detection of bone marrow abnormalities that are suspicious for leukemia in adult and pediatric patients with unclear musculoskeletal symptoms with its reduced radiation dose (in comparison with PET/CT). However, it may become more attractive with the use of newer, non-FDG PET radiotracers. High CXCR4 expression is known to be associated with poor prognosis in CLL. Recently, the feasibility of 68Ga-Pentixafor PET has also been demonstrated for CLL and AML. This prospective study is going to investigate the value of 68Ga-Pentixafor PET/CT for the diagnosis and prognostic evaluation of CXCR4 expression in leukemia.
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, PET/CT | Experimental | Drug: 68Ga-PentixaforPET/CT perform after injecting 68Ga-Pentixafor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- suspected or confirmed untreated Lymphoproliferative diseases patients
- 18F-FDG PET/CT within two weeks
- signed written consent.
Key exclusion criteria (3 listed)
- pregnancy
- breastfeeding
- known allergy against Pentixafor
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-PentixaforIntravenous injection of one dose of 74-148 MBq (2-4 mCi) 68Ga-Pentixafor. Tracer doses of 68Ga- Pentixafor will be used to image lesions by PET/CT. | Drug | 68Ga-Pentixafor, PET/CT |
Primary outcome
SUVmax
Time frame: through study completion, an average of 3 years
SUVmax of focal lesions are measured on 68Ga-Pentixafor PET/CT. The SUVmax of the liver, and/or mediastinal blood pool, and/or L3 vertebra are defined as the background.
The time for patient's survival
Time frame: through study completion, an average of 3 years
Investigators follow up and record the time for patient's survival. To investigate the ralationship between initial SUVmax of focal lesions and survival. Finally, the prognostic evaluation of 68Ga-Pentixafor PET/CT for lymphoproliferative diseases in comparison with 18F-FDG PET/CT.
1 secondary outcome
Diagnostic sensitivity and specficity in special type of lymphoma
Time frame: through study completion, an average of 3 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 21 Jul 2026.
- Derived from this study: PubMed 40540129Pan Q, Chen Z, Liu S, Zhang H, Feng J, Miao W, Li F, Cao X, Luo Y. Reduced splenic uptake of [68Ga]Ga-Pentixafor following first-line chemotherapy is associated with poor prognosis in patients with newly diagnosed multiple myeloma. EJNMMI Res. 2025 Jun 20;15(1):74. doi: 10.1186/s13550-025-01262-2.
- Derived from this study: PubMed 34651291Chen Z, Yang A, Zhang J, Chen A, Zhang Y, Huang C, Chen S, Yao S, Miao W. CXCR4-Directed PET/CT with [68Ga]Pentixafor in Central Nervous System Lymphoma: A Comparison with [18F]FDG PET/CT. Mol Imaging Biol. 2022 Jun;24(3):416-424. doi: 10.1007/s11307-021-01664-3. Epub 2021 Oct 14.
- 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.
Weibing Miao, M.D. principal investigator
First Affiliated Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 68Ga-Pentixafor in people with Lymphoma and Multiple Myeloma, run by First Affiliated Hospital of Fujian Medical University 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 3 inclusion and 3 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 21 Jul 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Weibing Miao, M.D. (+86-599-87981618, miaoweibing@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVmax (time frame: through study completion, an average of 3 years). The study lists 2 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 NCT04504526, which also lists 2 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 21 Jul 2026.