Hematological MalignanciesNCT06834412
A Study Evaluating the Value of 68Ga-Pentixafor PET Imaging in the Staging of Hematological Tumor, and Comparing It with 18F-FDG PET/CT Imaging
A study testing 68Ga-Pentixafor and 18F-FDG PET/CT Scan in people with Hematological Malignancies, run by Xijing Hospital at 1 site in China.
Trial summary
This is a prospective, open-label, single-center clinical study targeting hematological malignancies. 120 patients with a confirmed by pathology of non-Hodgkin's lymphoma or myeloma were included. Qualified subjects will undergo 18F-FDG PET/CT and 68Ga-Pentixafor PET/CT examination. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- 68Ga-Pentixafor and 18F-FDG PET/CT Scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2021to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 to 75 years old Confirmed by pathology with NHLs or myeloma Willing and able to follow the study protocol.
Who cannot join
- Children, pregnant or lactating women Severely impaired liver and kidney function (alanine aminotransferase > 8-10 times the upper limit of normal, serum creatinine 186-442 umol/L) With a history of allergy to contrast media or other drugs
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department ofNuclear Medicine,Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710000
Ying Guo, 0086+15991459177, guoying01192022@163.com
About this study
Official title: [68Ga]Pentixafor PET/CT for Staging of Hematological Malignancies: Comparison to [18F]FDG PET/CT
This is a prospective, open-label, single-center clinical study targeting hematological malignancies. 120 patients with a confirmed by pathology of non-Hodgkin's lymphoma or myeloma were included. Qualified subjects will undergo 18F-FDG PET/CT and 68Ga-Pentixafor PET/CT examination. The aim is to To investigate whether 68Ga-pentixafor PET imaging can be used as a reliable complement to 18F-FDG PET imaging for clinical staging, treatment response evaluation, and re-staging of patients with hematological malignancies.
- Conditions
- Hematological Malignancies
- Being tested
- 68Ga-Pentixafor and 18F-FDG PET/CT Scan
- Keywords
- 68Ga-Pentixafor, hematological malignancies, 18F-FDG, staging
- 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-Pentixafor and 18F-FDG PET/CT ScanDiagnostic test
The imaging agent 68Ga-Pentixafor and 18F-FDG used in this project is synthesized following the standards for radiopharmaceutical production, with reference to the Chinese Pharmacopoeia (quality standards for 18F-FDG). The pH value is about 4; the radiochemical purity is not less than 95%, and the bacterial endotoxin content in each milliliter of solution is less than 15EU; the radioactive concentration is not less than 37 MBq/mL; the solvent residues comply with the regulations. Specification: 185~1850 MBq/ml Characteristics: Clear, colorless, no visible particles. Radioactive physical half-life: 68Ga is 68 minutes. Expiry: Calculated from the time of labeling, stable for 3 half-lives. Administration method: Intravenous injection. Dosage: 0.05-0.1mCi/kg, flush with 5 mL of saline after injection.
| Study group | Role | What they receive |
|---|---|---|
| before-after study in the same patient | Experimental | This is a prospective, open-label, single-center clinical study for hematological malignancies. 120 patients confirmed by pathology of having NHLs or myeloma were included. Qualified subjects underwent 18F-FDG and 68Ga-Pentixafor PET/CT scans within 7 days after recruited. Patient medical history was collected and laboratory tests were performed before the examination, and a biopsy or surgery was performed to obtain pathological results within 1 month after the examination, followed by a 6-month follow-up. The pathological results were used as the diagnostic gold standard. Receives: Diagnostic Test: 68Ga-Pentixafor and 18F-FDG PET/CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Standardized uptake value (SUVmax)
Maximum Standardized uptake value (SUVmax) of [68Ga]Pentixafor and [18F]FDG in the included subjects' primary and/or metastatic lesions.
Measured: 1 day from injection of the tracer
Mean Standardized Uptake Value(SUVmean) of liver
Mean Standardized uptake value (SUVmean) of [68Ga]RCCB6 and [68Ga]PSMA in the included subjects' liver.
Measured: 1 day from injection of the tracer
Mean Standardized uptake value (SUVmean)
Mean Standardized uptake value (SUVmean) of [68Ga]Pentixafor and [18F]FDG in the included subjects' primary and/or metastatic lesions.
Measured: 1 day from injection of the tracer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start3 Nov 2021
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- before-after study in the same patient
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834412
- Sponsor's protocol ID
- KY20212119-F-1
- Other IDs
- KY20212119-F-1
- Status last verified
- Sep 2024
- First submitted
- 13 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu X, Tang H, Ou H, Quan Z, Li G, Gao G, Wang J, Kang F. Establishment and validation of a clinical threshold criteria for choosing PET imaging tracers for indolent non-Hodgkin's lymphoma. EJNMMI Res. 2025 Dec 27;16(1):17. doi: 10.1186/s13550-025-01368-7.
PubMed 41455028
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [68Ga]Pentixafor PET/CT for Staging of Hematological Malignancies: Comparison to [18F]FDG PET/CT
- ClinicalTrials.gov ID
- NCT06834412
- Acronym / sponsor ID
- KY20212119-F-1
- Conditions
- Hematological Malignancies
- Keywords
- 68Ga-Pentixafor, hematological malignancies, 18F-FDG, staging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 19 Feb 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.
This is a prospective, open-label, single-center clinical study targeting hematological malignancies. 120 patients with a confirmed by pathology of non-Hodgkin's lymphoma or myeloma were included. Qualified subjects will undergo 18F-FDG PET/CT and 68Ga-Pentixafor PET/CT examination. The aim is to To investigate whether 68Ga-pentixafor PET imaging can be used as a reliable complement to 18F-FDG PET imaging for clinical staging, treatment response evaluation, and re-staging of patients with hematological malignancies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- before-after study in the same patient
| Arm | Type | Receives |
|---|---|---|
| before-after study in the same patient | Experimental | Diagnostic Test: 68Ga-Pentixafor and 18F-FDG PET/CT ScanThis is a prospective, open-label, single-center clinical study for hematological malignancies. 120 patients confirmed by pathology of having NHLs or myeloma were included. Qualified subjects underwent 18F-FDG and 68Ga-Pentixafor PET/CT scans within 7 days after recruited. Patient medical history was collected and laboratory tests were performed before the examination, and a biopsy or surgery was performed to obtain pathological results within 1 month after the examination, followed by a 6-month follow-up. The pathological results were used as the diagnostic gold standard. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ages 18 to 75 years old Confirmed by pathology with NHLs or myeloma Willing and able to follow the study protocol.
Key exclusion criteria (1 listed)
- Children, pregnant or lactating women Severely impaired liver and kidney function (alanine aminotransferase > 8-10 times the upper limit of normal, serum creatinine 186-442 umol/L) With a history of allergy to contrast media or other drugs
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-Pentixafor and 18F-FDG PET/CT ScanThe imaging agent 68Ga-Pentixafor and 18F-FDG used in this project is synthesized following the standards for radiopharmaceutical production, with reference to the Chinese Pharmacopoeia (quality standards for 18F-FDG). The pH value is about 4; the radiochemical purity is not less than 95%, and the bacterial endotoxin content in each milliliter of solution is less than 15EU; the radioactive concentration is not less than 37 MBq/mL; the solvent residues comply with the regulations. Specification: 185~1850 MBq/ml Characteristics: Clear, colorless, no visible particles. Radioactive physical half-life: 68Ga is 68 minutes. Expiry: Calculated from the time of labeling, stable for 3 half-lives. Administration method: Intravenous injection. Dosage: 0.05-0.1mCi/kg, flush with 5 mL of saline after injection. | Diagnostic test | before-after study in the same patient |
Primary outcome
Maximum Standardized uptake value (SUVmax)
Time frame: 1 day from injection of the tracer
Maximum Standardized uptake value (SUVmax) of [68Ga]Pentixafor and [18F]FDG in the included subjects' primary and/or metastatic lesions.
Mean Standardized Uptake Value(SUVmean) of liver
Time frame: 1 day from injection of the tracer
Mean Standardized uptake value (SUVmean) of [68Ga]RCCB6 and [68Ga]PSMA in the included subjects' liver.
Mean Standardized uptake value (SUVmean)
Time frame: 1 day from injection of the tracer
Mean Standardized uptake value (SUVmean) of [68Ga]Pentixafor and [18F]FDG in the included subjects' primary and/or metastatic lesions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Derived from this study: PubMed 41455028Yu X, Tang H, Ou H, Quan Z, Li G, Gao G, Wang J, Kang F. Establishment and validation of a clinical threshold criteria for choosing PET imaging tracers for indolent non-Hodgkin's lymphoma. EJNMMI Res. 2025 Dec 27;16(1):17. doi: 10.1186/s13550-025-01368-7.
- 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. This study is not recruiting at the moment.
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 18F-FDG PET/CT Scan in people with Hematological Malignancies, run by Xijing 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Guo (0086+15991459177, guoying01192022@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Standardized uptake value (SUVmax) (time frame: 1 day from injection of the tracer). The study lists 3 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 NCT06834412, which also lists 1 linked publication.
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 3 Mar 2025.