GliomaNCT06234319
CXCR4 PET/MRI Targeted Imaging for Grading Diagnosis, Molecular Typing, and Prognostic Evaluation of Brain Glioma
An observational study of Glioma, run by Xiao Chen at 1 site in China.
Trial summary
This project intends to evaluate the role of C-X-C chemokine receptor type 4 (CXCR4) targeted PET/MRI integrated imaging in the grading and molecular typing of brain gliomas, using primary glioma patients as the research subjects and post-operative histopathological analysis as the reference, and to establish an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- CXCR4
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2024to 31 Dec 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects are adults with newly diagnosed primary glioma, regardless of gender.
Who may be able to join
- Patients diagnosed with primary glioma based on clinical, imaging, and histopathological criteria;
- The patient is at least 18 years old;
- Participate in CXCR4 PET/MRI imaging within 15 days before surgery;
- Surgical resection of glioma lesion tissue can be used for pathological analysis;
- The patient voluntarily participates and signs the informed consent form.
Who cannot join
- Pregnant or breastfeeding patients;
- The image quality of the imaging is poor and cannot be used for diagnosis and evaluation;
- Molecular typing was not determined by histologic examination;
- patients with claustrophobia;
- Patients who are allergic to radioactive tracers and MRI contrast agents, and patients with renal insufficiency.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nuclear Medicine, Daping Hospital of Army Medical University
Chongqing, Chongqing Municipality, 400000
Chen Xiao, +8615922970174, xiaochen229@foxmail.com
Du Zhenwei, +8618580503880, peter11dzw@126.com
About this study
Official title: Clinical Study on CXCR4 PET/MRI Targeted Integrated Imaging for Grading Diagnosis, Molecular Typing, and Prognostic Evaluation of Brain Glioma
This project intends to evaluate the role of C-X-C chemokine receptor type 4 (CXCR4) targeted PET/MRI integrated imaging in the grading and molecular typing of brain gliomas, using primary glioma patients as the research subjects and post-operative histopathological analysis as the reference, and to establish an evaluation model for the prognosis of primary glioma patients.
Read the detailed description
- PET/MRI Scan: Image acquisition was completed 15 days before surgery. CXCR4 contrast agent was injected at 6.5 MBq/kg based on body mass, with no drug extravasation, and imaging was performed after 60 minutes of quiet rest. All subjects were scanned in a supine position on a single bed of the Signa™ 3.0T scanner (GE Healthcare Systems), using a 3.0T gem HNU head coil with a scanning field of view focused on the head. PET acquisition lasted for 20 minutes and was reconstructed using OSEM. Simultaneous MRI acquisition included MR-based attenuation correction (MRAC) - zero echo time pulse sequence (ZTE), as well as structural and functional MRI sequences (T1WI, T2WI, FLAIR, DWI, MRS, DSC, T1-CE). Image fusion was performed on a GE post-processing workstation.
- Image Analysis and Observation Indicators: PET/MRI images were independently reviewed and processed by two experienced neuroradiologists. Using IKT-SNAP software, target lesion VOIs were outlined based on FLAIR and T1-CE sequences. VOI delineation on the FLAIR sequence included solid tumor components, necrotic areas, and surrounding abnormal FLAIR signal regions. VOI delineation on the T1-CE sequence included enhanced solid components, non-enhanced solid components, and necrotic areas. MRI parameters (diffusion-weighted imaging parameters: ADC; perfusion imaging parameters: CBF, CBV, MTT, TTP; spectroscopic parameters: NAA, Cho, Cr, Lac, NAA/Cr, Cho/Cr) and PET parameters (SUVmax, SUVmean, SUVpeak, CXCR4 metabolic volume, TBR) were measured throughout the tumor and corresponding regions.
- Pathological Analysis: Slices containing no less than 25% tumor tissue were used, with each slice having a thickness of 4um. HE, CD34, and CXCR4 immunohistochemical staining were performed separately. Two senior pathologists reviewed the slides using a double-blind method. IDH mutation status and 1p/19q deletion status were determined by the pathology department.
- Conditions
- Glioma
- Being tested
- CXCR4
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CXCR4Diagnostic test
Patients with clinical suspected primary glioma will receive a CXCR4 PET imaging.
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardised uptake values
Standardised uptake values of suspected glioma disease in CXCR4 PET/MRI imaging
Measured: completed within one week after the PET/MRI examination
expression of CD34
Immunohistochemical evaluation of the expression of CD34 in postoperative tumor tissue
Measured: completed within one week after surgery
expression of CXCR4
Immunohistochemical evaluation of the expression of CXCR4 in postoperative tumor tissue
Measured: completed within one week after surgery
Secondary outcomes (4)
SUV and histological grading of glioma
Correlation between SUV and histological grading of glioma
Measured: through study completion, an average of 1 year
CXCR4 expression and histological grading of glioma
Correlation between CXCR4 expression and histological grading of glioma
Measured: through study completion, an average of 1 year
SUV and IDH mutation status
Correlation between SUV and IDH mutation status
Measured: through study completion, an average of 1 year
SUV and 1p/19q deletion status
Correlation between SUV and 1p/19q deletion status
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start15 Feb 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 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 GliomaStudies 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
- 60 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Xiao Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiao Chen, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- Chen Xiao, Ph.D, Principal investigator, Daping Hospital, Army Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234319
- Sponsor's protocol ID
- 20230294
- Status last verified
- Mar 2024
- First submitted
- 4 Jan 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jacobs SM, Wesseling P, de Keizer B, Tolboom N, Ververs FFT, Krijger GC, Westerman BA, Snijders TJ, Robe PA, van der Kolk AG. CXCR4 expression in glioblastoma tissue and the potential for PET imaging and treatment with [68Ga]Ga-Pentixafor /[177Lu]Lu-Pentixather. Eur J Nucl Med Mol Imaging. 2022 Jan;49(2):481-491. doi: 10.1007/s00259-021-05196-4. Epub 2021 Feb 7.
PubMed 33550492
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on CXCR4 PET/MRI Targeted Integrated Imaging for Grading Diagnosis, Molecular Typing, and Prognostic Evaluation of Brain Glioma
- ClinicalTrials.gov ID
- NCT06234319
- Acronym / sponsor ID
- 20230294
- Conditions
- Glioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xiao ChenUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 Jan 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.
This project intends to evaluate the role of C-X-C chemokine receptor type 4 (CXCR4) targeted PET/MRI integrated imaging in the grading and molecular typing of brain gliomas, using primary glioma patients as the research subjects and post-operative histopathological analysis as the reference, and to establish an evaluation model for the prognosis of primary glioma patients.
Detailed description
- PET/MRI Scan: Image acquisition was completed 15 days before surgery. CXCR4 contrast agent was injected at 6.5 MBq/kg based on body mass, with no drug extravasation, and imaging was performed after 60 minutes of quiet rest. All subjects were scanned in a supine position on a single bed of the Signa™ 3.0T scanner (GE Healthcare Systems), using a 3.0T gem HNU head coil with a scanning field of view focused on the head. PET acquisition lasted for 20 minutes and was reconstructed using OSEM. Simultaneous MRI acquisition included MR-based attenuation correction (MRAC) - zero echo time pulse sequence (ZTE), as well as structural and functional MRI sequences (T1WI, T2WI, FLAIR, DWI, MRS, DSC, T1-CE). Image fusion was performed on a GE post-processing workstation.
- Image Analysis and Observation Indicators: PET/MRI images were independently reviewed and processed by two experienced neuroradiologists. Using IKT-SNAP software, target lesion VOIs were outlined based on FLAIR and T1-CE sequences. VOI delineation on the FLAIR sequence included solid tumor components, necrotic areas, and surrounding abnormal FLAIR signal regions. VOI delineation on the T1-CE sequence included enhanced solid components, non-enhanced solid components, and necrotic areas. MRI parameters (diffusion-weighted imaging parameters: ADC; perfusion imaging parameters: CBF, CBV, MTT, TTP; spectroscopic parameters: NAA, Cho, Cr, Lac, NAA/Cr, Cho/Cr) and PET parameters (SUVmax, SUVmean, SUVpeak, CXCR4 metabolic volume, TBR) were measured throughout the tumor and corresponding regions.
- Pathological Analysis: Slices containing no less than 25% tumor tissue were used, with each slice having a thickness of 4um. HE, CD34, and CXCR4 immunohistochemical staining were performed separately. Two senior pathologists reviewed the slides using a double-blind method. IDH mutation status and 1p/19q deletion status were determined by the pathology department.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects are adults with newly diagnosed primary glioma, regardless of gender.
Key inclusion criteria (5 listed)
- Patients diagnosed with primary glioma based on clinical, imaging, and histopathological criteria;
- The patient is at least 18 years old;
- Participate in CXCR4 PET/MRI imaging within 15 days before surgery;
- Surgical resection of glioma lesion tissue can be used for pathological analysis;
- The patient voluntarily participates and signs the informed consent form.
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding patients;
- The image quality of the imaging is poor and cannot be used for diagnosis and evaluation;
- Molecular typing was not determined by histologic examination;
- patients with claustrophobia;
- Patients who are allergic to radioactive tracers and MRI contrast agents, and patients with renal insufficiency.
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 |
|---|---|---|
| CXCR4Patients with clinical suspected primary glioma will receive a CXCR4 PET imaging. | Diagnostic test | – |
Primary outcome
Standardised uptake values
Time frame: completed within one week after the PET/MRI examination
Standardised uptake values of suspected glioma disease in CXCR4 PET/MRI imaging
expression of CD34
Time frame: completed within one week after surgery
Immunohistochemical evaluation of the expression of CD34 in postoperative tumor tissue
expression of CXCR4
Time frame: completed within one week after surgery
Immunohistochemical evaluation of the expression of CXCR4 in postoperative tumor tissue
4 secondary outcomes
SUV and histological grading of glioma
Time frame: through study completion, an average of 1 year
CXCR4 expression and histological grading of glioma
Time frame: through study completion, an average of 1 year
SUV and IDH mutation status
Time frame: through study completion, an average of 1 year
SUV and 1p/19q deletion status
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Results publication: PubMed 33550492Jacobs SM, Wesseling P, de Keizer B, Tolboom N, Ververs FFT, Krijger GC, Westerman BA, Snijders TJ, Robe PA, van der Kolk AG. CXCR4 expression in glioblastoma tissue and the potential for PET imaging and treatment with [68Ga]Ga-Pentixafor /[177Lu]Lu-Pentixather. Eur J Nucl Med Mol Imaging. 2022 Jan;49(2):481-491. doi: 10.1007/s00259-021-05196-4. Epub 2021 Feb 7.
- Individual participant dataSharing planned: No
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RecruitingPhase 1/2
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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.
Chen Xiao, Ph.D principal investigator
Daping Hospital, Army Medical University
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 Glioma, run by Xiao Chen 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: status not confirmed, as of the sponsor's last update on 5 Mar 2024. 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 Du ZHenwei, Ph.D (+8618580503880, peter11dzw@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardised uptake values (time frame: completed within one week after the PET/MRI examination). 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 NCT06234319, 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 5 Mar 2024.