Hematological MalignanciesNCT07122674
18F-Pentixafor PET in Hematologic Malignancies
An observational study of Hematological Malignancies, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
The aim of this study is to evaluate the efficacy of 18F-Pentixafor PET imaging in the diagnosis, staging and response evaluation of hematological malignancies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- 18F-Pentixafor
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to Dec 2029
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with suspected or confirmed Hematologic Malignancies
Who may be able to join
- Age of 18-80 years old, both sexes, with behavioral capacity;
- patients with suspected or confirmed hematological malignancies;
- 18F-FDG PET or other imaging examinations should be performed according to the treatment plan;
- For suspected patients, biopsy or needle biopsy is expected to obtain pathological results;
- Can provide informed consent, can understand and comply with the requirements of the study.
Who cannot join
- pregnant and lactating women;
- patients with fear or radiophobia, or with mental disorder or primary affective disorder;
- received ionizing radiation outside the scope of this study for clinical medical or scientific research purposes within the past year, resulting in an annual radiation exposure dose exceeding 50 mSv;
- received investigational drugs or devices of uncertain efficacy or safety within 1 month;
- Any condition that the chairpersons of the study consider that any link related to the study may cause harm or have potential harm.
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
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Xinhui Su, MD, 86 13806071262, suxinhui@zju.edu.cn
Peipei Wang, MD, 86 18511395988, wpp199411@163.com
About this study
Official title: Prospective Clinical Study of 18F-Pentixafor PET Imaging in Hematologic Malignancies
The aim of this study is to evaluate the efficacy of 18F-Pentixafor PET imaging in the diagnosis, staging and response evaluation of hematological malignancies.
Read the detailed description
18F-FDG PET imaging based on the principle of glucose metabolism imaging is currently dominant in the staging and efficacy evaluation of lymphoma, but it is not suitable for a wider range of hematological tumors. Chemokine receptor 4 (CXCR-4) is a G protein-coupled receptor, which is overexpressed in a variety of hematological malignancies (MM, leukemia, lymphoma, etc.). It promotes tumor growth, invasion, metastasis, drug resistance, immune escape, and is associated with poor prognosis of tumors. 18Fluorine18 (18F)-NOTA-Pentixafor (18f-pentixafor) is a novel specific molecular probe targeting CXCR-4. Compared with 68Ga-Pentixafor, 18f-pentixafor has a longer half-life. More patients can be used in one synthesis, and the image quality is better and the spatial resolution is higher. Patients can undergo PET at 1 h after injection without special preparation. The aim of this study is to evaluate the performance of 18F-Pentixafor PET imaging in the diagnosis, staging, and response evaluation of hematological malignancies. Patients with suspected or histologically confirmed hematological malignancies will be enrolled in this study.
- Conditions
- Hematological Malignancies
- Being tested
- 18F-Pentixafor
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-PentixaforDrug
Patients with hematological malignancies receive 55 MBq/kg of 18F-Pentixafor intravenously followed by PET/CT or PET/MR after 60min of injection.
| Study group | Role | What they receive |
|---|---|---|
| 18F-Pentixafor PET/CT in Hematologic Malignancies | Each patient receive a single intravenous injection of 18F-Pentixafor 55 MBq/kg and undergo PET/CT or PET/MR scan after 60 min post-injection. Receives: Drug: 18F-Pentixafor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic efficacy
Sensitivity, specificity, positive and negative predictive value of 18F-Pentixafor PET/CT and PET/MR Imaging in hematological malignancies.
Measured: through study completion, an average of 1.5 year
Secondary outcomes (2)
18F-Pentixafor PET performence compared with 18F-FDG
Differences in sensitivity and specificity: McNemar test Differences in AUC values: DeLong test Detection rate of lesions: chi-square test. SUVmax/TBR difference: Paired t-test (normal distribution) or Wilcoxon signed-rank test (non-normal) Correlation analysis: Spearman's rank correlation was used to assess the correlation of uptake between the two imaging methods.
Subgroup analysis: Chi-square test or Logistic regression was used to analyze heterogeneity in diagnostic power stratified by disease type and stage.
Measured: up to 24 months
Deauville Score
- Score consistency analysis Agreement with 18F-FDG: Calculated agreement between the two imaging scores for the same patient (percentage agreement \& Cohen's Kappa).
- correlation between scores and clinical outcomes Prediction of treatment response: use the International Working Group criteria (Lugano classification) as the gold standard (complete response CR, partial response PR, etc.) The association between 18F-Pentixafor scores (e.g., DS≤3 vs. DS≥4 after treatment) and treatment response (chi-square test) was calculated. Prognostic Value: Analyze the association of 18F-Pentixafor score (e.g., baseline DS≥4) with progression-free survival (PFS) or overall survival (OS) (Cox proportional-hazards model). The prognostic efficacy of 18F-Pentixafor and 18F-FDG scoring was compared (area under the ROC curve, AUC).
- score critical value optimization:If the physiological profiles of 18F-Pentixafor and 18F-FDG differ significantly (e.g., higher hepatic uptake), explore adjusted cutoffs
Measured: through study completion, 3-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Jul 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122674
- Sponsor's protocol ID
- FAHZU-CXCR4-Hemic
- Status last verified
- May 2025
- First submitted
- 7 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study of 18F-Pentixafor PET Imaging in Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT07122674
- Acronym / sponsor ID
- FAHZU-CXCR4-Hemic
- Conditions
- Hematological Malignancies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 14 Aug 2025 (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.
The aim of this study is to evaluate the efficacy of 18F-Pentixafor PET imaging in the diagnosis, staging and response evaluation of hematological malignancies.
Detailed description
18F-FDG PET imaging based on the principle of glucose metabolism imaging is currently dominant in the staging and efficacy evaluation of lymphoma, but it is not suitable for a wider range of hematological tumors. Chemokine receptor 4 (CXCR-4) is a G protein-coupled receptor, which is overexpressed in a variety of hematological malignancies (MM, leukemia, lymphoma, etc.). It promotes tumor growth, invasion, metastasis, drug resistance, immune escape, and is associated with poor prognosis of tumors. 18Fluorine18 (18F)-NOTA-Pentixafor (18f-pentixafor) is a novel specific molecular probe targeting CXCR-4. Compared with 68Ga-Pentixafor, 18f-pentixafor has a longer half-life. More patients can be used in one synthesis, and the image quality is better and the spatial resolution is higher. Patients can undergo PET at 1 h after injection without special preparation. The aim of this study is to evaluate the performance of 18F-Pentixafor PET imaging in the diagnosis, staging, and response evaluation of hematological malignancies. Patients with suspected or histologically confirmed hematological malignancies will be enrolled in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-Pentixafor PET/CT in Hematologic Malignancies | – | Drug: 18F-PentixaforEach patient receive a single intravenous injection of 18F-Pentixafor 55 MBq/kg and undergo PET/CT or PET/MR scan after 60 min post-injection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with suspected or confirmed Hematologic Malignancies
Key inclusion criteria (5 listed)
- Age of 18-80 years old, both sexes, with behavioral capacity;
- patients with suspected or confirmed hematological malignancies;
- 18F-FDG PET or other imaging examinations should be performed according to the treatment plan;
- For suspected patients, biopsy or needle biopsy is expected to obtain pathological results;
- Can provide informed consent, can understand and comply with the requirements of the study.
Key exclusion criteria (5 listed)
- pregnant and lactating women;
- patients with fear or radiophobia, or with mental disorder or primary affective disorder;
- received ionizing radiation outside the scope of this study for clinical medical or scientific research purposes within the past year, resulting in an annual radiation exposure dose exceeding 50 mSv;
- received investigational drugs or devices of uncertain efficacy or safety within 1 month;
- Any condition that the chairpersons of the study consider that any link related to the study may cause harm or have potential harm.
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 |
|---|---|---|
| 18F-PentixaforPatients with hematological malignancies receive 55 MBq/kg of 18F-Pentixafor intravenously followed by PET/CT or PET/MR after 60min of injection. | Drug | 18F-Pentixafor PET/CT in Hematologic Malignancies |
Primary outcome
Diagnostic efficacy
Time frame: through study completion, an average of 1.5 year
Sensitivity, specificity, positive and negative predictive value of 18F-Pentixafor PET/CT and PET/MR Imaging in hematological malignancies.
2 secondary outcomes
18F-Pentixafor PET performence compared with 18F-FDG
Time frame: up to 24 months
Deauville Score
Time frame: through study completion, 3-4 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 14 Aug 2025.
Related trials for Hematological Malignancies
Recruiting
HEME Home Transfusion Program
Leukemia, Myeloma
RecruitingObservational study
Avera Cancer Sequencing and Analytics Protocol (ASAP)
Cancer, Cancer Diagnosis
Recruiting
Involvement of CDA and/or dCK Metabolizing Enzymes in the Response to Azacytidine Treatment of Patients With Hematologic Malignancies
Myelodysplastic Syndromes (MDS), Leukemia Acute Myeloid - AML
Not yet recruitingPhase 2
Stem Cell Transplantation for Participants With Germline RUNX1 Associated Blood Cancers
Core Binding Factor Alpha Subunits, Hematologic Neoplasms
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematological Malignancies, run by First Affiliated Hospital of Zhejiang 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 5 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 14 Aug 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 Peipei Wang, MD (86 18511395988, wpp199411@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic efficacy (time frame: through study completion, an average of 1.5 year). 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 14 Aug 2025.