Non Hodgkin's LymphomaNCT06720207
Efficacy of 68Ga-Pentixafor PET/MR in Detecting Non-Hodgkin Lymphoma and Multiple Myeloma Lesions
An observational study of Non Hodgkin's Lymphoma and Multiple Myeloma (MM), run by Shanghai East Hospital.
Trial summary
In this study, the investigators intend to utilize 68Ga-Pentixafor Positron Emission Tomography(PET) imaging for patients diagnosed with non-Hodgkin lymphoma (NHL) and multiple myeloma (MM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin's Lymphoma, Multiple Myeloma (MM)
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 31 Jul 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who meet the inclusion and exclusion criteria and are willing to follow the research process.
Who may be able to join
- Age of 18 years or older
- ECOG < 2
- Newly diagnosed patients with NHL and MM who have been confirmed or are highly suspected based on pathological examination
- Completion of 18F-FDG PET/CT or PET/MR imaging within the past week in our department
Who cannot join
- Pregnant and breastfeeding women;
- Individuals with severe hepatic and renal failure;
- Patients with concurrent malignancies;
- Individuals unable to remain supine for a duration of 30 minutes to complete the examination;
- Patients with diagnosed claustrophobia;
- Patients containing metallic implants;
- Individuals deemed unsuitable for participation in clinical trials by researchers.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Exploratory Study on the Efficacy of 68Ga-Pentixafor PET/MR in Detecting Lesions in Non-Hodgkin Lymphoma and Multiple Myeloma
In this study, the investigators intend to utilize 68Ga-Pentixafor Positron Emission Tomography(PET) imaging for patients diagnosed with non-Hodgkin lymphoma (NHL) and multiple myeloma (MM). The investigators will compare the imaging results with those obtained from 18F-FDG imaging, and a correlation analysis will be performed to assess progression-free survival among patients. This analysis aims to evaluate the diagnostic efficacy and the potential for early prediction of treatment efficacy associated with 68Ga-Pentixafor in these specific conditions.
Read the detailed description
The hematolymphatic system comprises blood, lymph nodes, extranodal lymphatic tissues, bone marrow, and the spleen. When malignant transformations occur within this system, they often infiltrate various tissues and organs throughout the body. Therefore, a comprehensive assessment of all tissues and organs is necessary to delineate the lesions' extent and conduct clinical staging to guide treatment. Lymphoma is the most prevalent malignancy of the hematologic system, with non-Hodgkin lymphoma (NHL) accounting for a significant incidence within this category, representing approximately 90% of lymphomas in our country. The clinical classification of NHL is complex, exhibiting considerable heterogeneity in biological behavior, immunophenotyping, and prognosis. The main subtypes include diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), T-cell lymphoma (TCL), marginal zone lymphomas (MZL), and mantle cell lymphoma (MCL). Multiple myeloma (MM) is a malignant disease characterized by the clonal proliferation of abnormal plasma cells and is the second most common hematologic malignancy following lymphoma. Common symptoms include organ dysfunction related to myeloma, encapsulated in the "CRAB" criteria-hypercalcemia, renal insufficiency, anemia, and bone disease-along with manifestations of organ damage due to amyloidosis. The prognosis is poor if patients do not receive timely and effective treatment.
Chemokine receptor 4 (CXCR4) is a member of the C-X-C motif (CXC) subfamily of chemokine receptors and is widely expressed in various types of organ tissue. It significantly regulates numerous physiological processes through interaction with CXC-chemokine ligand 12 (CXCL12). The CXCR4/CXCL12 biological axis is critical in the proliferation, invasion, and metastasis of NHL and MM and is considered a marker of poor prognosis. Recently, a new positron emission tomography (PET) tracer targeting CXCR4, 68Ga-Pentixafor, has been developed and is being increasingly utilized to diagnose hematological malignancies. The 68Ga-Pentixafor PET demonstrates notable advantages in identifying lymphoma, particularly indolent types, as well as in detecting early small lesions associated with MM. It shows greater sensitivity compared to 18F-fluorodeoxyglucose (FDG) imaging. This advancement not only enhances patient diagnosis and efficacy evaluation but also functions as a biological targeting molecule for individuals with poor prognostic outcomes, enabling these patients to access more intensive treatment options.
18F-fluorodeoxyglucose (FDG) is the most widely used tracer in nuclear medicine for tumor imaging, applicable to the initial staging and efficacy assessment of the vast majority of tumors. According to the 2021 guidelines from the Chinese Medical Association's Nuclear Medicine Branch and recommendations from the International Myeloma Working Group (IMWG), 18F-FDG positron emission tomography / computed tomography (PET/CT) imaging is recommended for the diagnostic and therapeutic management of all lymphoma and MM patients. However, it is important to note that the uptake of FDG in NHL is related to its pathological type; DLBCL and FL typically exhibit high FDG uptake, while MZL, MCL, and small lymphocytic lymphoma(SLL) usually show moderate to low FDG uptake. This variability results in differences in the diagnostic accuracy of 18F-FDG PET depending on the subtype of NHL. Additionally, approximately 11% of MM patients may present with false-negative FDG imaging, which could be attributed to factors such as small lesion size, a lower proliferation rate of clonal plasma cells, or hexokinase deficiency. Furthermore, physiological or inflammatory uptake of 18F-FDG can sometimes interfere with the detection of MM lesions.
In summary, early diagnosis before treatment, precise staging, and post-treatment prognostic stratification, as well as the detection of residual tumor metabolic activity, represent significant challenges in the diagnosis and treatment of NHL and MM. The use of 68Ga-pentixafor PET/MR allows for non-invasive visualization of CXCR4 expression in vivo, demonstrating high sensitivity for NHL and MM with low FDG uptake. This capability enhances diagnostic accuracy and facilitates precise staging, contributing to the development of personalized treatment plans and ultimately improving patient outcomes. Through the implementation of this project, the investigators aim to introduce new technologies in the management of NHL and MM patients, providing more effective diagnostic and therapeutic options.
- Conditions
- Non Hodgkin's Lymphoma, Multiple Myeloma (MM)
- Keywords
- PET/MR, Non Hodgkin's Lymphoma, multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Research group | It is expected to include 30 newly diagnosed NHL or MM patients, and the tracer radiation used in the study is extremely small and will not have any physiological effects on the subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ann Arbor staging
All patients were classified into stages I-IV based on Ann Arbor staging according to visual methods.
Measured: After the patient signs the informed consent form and completes the scan, an average of 2 days.
Metabolic parameters
Calculate maximum standardized uptake value (SUVmax (lesion)) of all affected lymphoma and extranodal organs. Set a region of interest with a diameter of approximately 10mm in the descending segment of the thoracic aorta, calculate the standardized uptake value (SUVmean) of the mediastinal blood pool, calculate SUVmax (lesion)/SUVmean (blood pool).
Measured: After the patient signs the informed consent form and completes the scan, an average of 2 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Jul 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin's LymphomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720207
- Sponsor's protocol ID
- SEH-2024210
- Status last verified
- Dec 2024
- First submitted
- 27 Nov 2024
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For the protection of patient privacy, we will not share patient information, but other researchers can apply through the project contact person if they have reasonable reasons.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Efficacy of 68Ga-Pentixafor PET/MR in Detecting Lesions in Non-Hodgkin Lymphoma and Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06720207
- Acronym / sponsor ID
- SEH-2024210
- Conditions
- Non Hodgkin's Lymphoma, Multiple Myeloma (MM)
- Keywords
- PET/MR, Non Hodgkin's Lymphoma, multiple myeloma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 6 Dec 2024 (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.
In this study, the investigators intend to utilize 68Ga-Pentixafor Positron Emission Tomography(PET) imaging for patients diagnosed with non-Hodgkin lymphoma (NHL) and multiple myeloma (MM). The investigators will compare the imaging results with those obtained from 18F-FDG imaging, and a correlation analysis will be performed to assess progression-free survival among patients. This analysis aims to evaluate the diagnostic efficacy and the potential for early prediction of treatment efficacy associated with 68Ga-Pentixafor in these specific conditions.
Detailed description
The hematolymphatic system comprises blood, lymph nodes, extranodal lymphatic tissues, bone marrow, and the spleen. When malignant transformations occur within this system, they often infiltrate various tissues and organs throughout the body. Therefore, a comprehensive assessment of all tissues and organs is necessary to delineate the lesions' extent and conduct clinical staging to guide treatment. Lymphoma is the most prevalent malignancy of the hematologic system, with non-Hodgkin lymphoma (NHL) accounting for a significant incidence within this category, representing approximately 90% of lymphomas in our country. The clinical classification of NHL is complex, exhibiting considerable heterogeneity in biological behavior, immunophenotyping, and prognosis. The main subtypes include diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), T-cell lymphoma (TCL), marginal zone lymphomas (MZL), and mantle cell lymphoma (MCL). Multiple myeloma (MM) is a malignant disease characterized by the clonal proliferation of abnormal plasma cells and is the second most common hematologic malignancy following lymphoma. Common symptoms include organ dysfunction related to myeloma, encapsulated in the "CRAB" criteria-hypercalcemia, renal insufficiency, anemia, and bone disease-along with manifestations of organ damage due to amyloidosis. The prognosis is poor if patients do not receive timely and effective treatment.
Chemokine receptor 4 (CXCR4) is a member of the C-X-C motif (CXC) subfamily of chemokine receptors and is widely expressed in various types of organ tissue. It significantly regulates numerous physiological processes through interaction with CXC-chemokine ligand 12 (CXCL12). The CXCR4/CXCL12 biological axis is critical in the proliferation, invasion, and metastasis of NHL and MM and is considered a marker of poor prognosis. Recently, a new positron emission tomography (PET) tracer targeting CXCR4, 68Ga-Pentixafor, has been developed and is being increasingly utilized to diagnose hematological malignancies. The 68Ga-Pentixafor PET demonstrates notable advantages in identifying lymphoma, particularly indolent types, as well as in detecting early small lesions associated with MM. It shows greater sensitivity compared to 18F-fluorodeoxyglucose (FDG) imaging. This advancement not only enhances patient diagnosis and efficacy evaluation but also functions as a biological targeting molecule for individuals with poor prognostic outcomes, enabling these patients to access more intensive treatment options.
18F-fluorodeoxyglucose (FDG) is the most widely used tracer in nuclear medicine for tumor imaging, applicable to the initial staging and efficacy assessment of the vast majority of tumors. According to the 2021 guidelines from the Chinese Medical Association's Nuclear Medicine Branch and recommendations from the International Myeloma Working Group (IMWG), 18F-FDG positron emission tomography / computed tomography (PET/CT) imaging is recommended for the diagnostic and therapeutic management of all lymphoma and MM patients. However, it is important to note that the uptake of FDG in NHL is related to its pathological type; DLBCL and FL typically exhibit high FDG uptake, while MZL, MCL, and small lymphocytic lymphoma(SLL) usually show moderate to low FDG uptake. This variability results in differences in the diagnostic accuracy of 18F-FDG PET depending on the subtype of NHL. Additionally, approximately 11% of MM patients may present with false-negative FDG imaging, which could be attributed to factors such as small lesion size, a lower proliferation rate of clonal plasma cells, or hexokinase deficiency. Furthermore, physiological or inflammatory uptake of 18F-FDG can sometimes interfere with the detection of MM lesions.
In summary, early diagnosis before treatment, precise staging, and post-treatment prognostic stratification, as well as the detection of residual tumor metabolic activity, represent significant challenges in the diagnosis and treatment of NHL and MM. The use of 68Ga-pentixafor PET/MR allows for non-invasive visualization of CXCR4 expression in vivo, demonstrating high sensitivity for NHL and MM with low FDG uptake. This capability enhances diagnostic accuracy and facilitates precise staging, contributing to the development of personalized treatment plans and ultimately improving patient outcomes. Through the implementation of this project, the investigators aim to introduce new technologies in the management of NHL and MM patients, providing more effective diagnostic and therapeutic options.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research group | – | –It is expected to include 30 newly diagnosed NHL or MM patients, and the tracer radiation used in the study is extremely small and will not have any physiological effects on the subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who meet the inclusion and exclusion criteria and are willing to follow the research process.
Key inclusion criteria (4 listed)
- Age of 18 years or older
- ECOG < 2
- Newly diagnosed patients with NHL and MM who have been confirmed or are highly suspected based on pathological examination
- Completion of 18F-FDG PET/CT or PET/MR imaging within the past week in our department
Key exclusion criteria (7 listed)
- Pregnant and breastfeeding women;
- Individuals with severe hepatic and renal failure;
- Patients with concurrent malignancies;
- Individuals unable to remain supine for a duration of 30 minutes to complete the examination;
- Patients with diagnosed claustrophobia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ann Arbor staging
Time frame: After the patient signs the informed consent form and completes the scan, an average of 2 days.
All patients were classified into stages I-IV based on Ann Arbor staging according to visual methods.
Metabolic parameters
Time frame: After the patient signs the informed consent form and completes the scan, an average of 2 days.
Calculate maximum standardized uptake value (SUVmax (lesion)) of all affected lymphoma and extranodal organs. Set a region of interest with a diameter of approximately 10mm in the descending segment of the thoracic aorta, calculate the standardized uptake value (SUVmean) of the mediastinal blood pool, calculate SUVmax (lesion)/SUVmean (blood pool).
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 27 Jun 2025.
- Individual participant dataSharing planned: No. For the protection of patient privacy, we will not share patient information, but other researchers can apply through the project contact person if they have reasonable reasons.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Hodgkin's Lymphoma and Multiple Myeloma (MM), run by Shanghai East Hospital.
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 7 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: opening soon, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Jie Ding, MD (086-38804518, dingjie940406@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ann Arbor staging (time frame: After the patient signs the informed consent form and completes the scan, an average of 2 days.). 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?
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 27 Jun 2025.