Diagnoses DiseaseAPTNCT03180697
The Efficacy of APT Magnetic Resonance Imaging in Predicting the Efficacy of Bevacizumab in Recurrent Malignant Gliomas
An observational study of Diagnoses Disease and Glioma of Brain, run by Zhujiang Hospital at 1 site in China.
Trial summary
Targeted therapy with bevacizumab is the main method to prolong the progression-free survival of patients with recurrent malignant gliomas in recent years. Using noninvasive imaging methods to predict which RMG may respond to bevacizumab regimen therapy is a clinical problem ; on the other hand, repeated gadolinium… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diagnoses Disease, Glioma of Brain
- What is being tested?
- APT MR Imaging
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2017to 1 Oct 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 patients with recurrent maligant glioma will be recuritted. All the patients are eligible for the inclusive criteria.
Who may be able to join
- malignant glioma patients at least 4 weeks after surgery;
- after radiotherapy or chemotherapy after the recurrence, stop to put,
- the age of patients ≥ 18 years old;
- bone marrow, liver and kidney function is good;
- not using steroid hormones or disabled for more than 5 days;
- patients are generally in good condition, expected survival is greater than 8 weeks, Karnofsky test is greater than 60.
Who cannot join
- patients with refractory hypertension, active vascular disease, bleeding, intestinal perforation and other medical history;
- frail and difficult to tolerate treatment;
- HIV positive;
- pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510282
Xiaoxiao Wu, Master, +862061643022, zjyyyxllwyh@163.com
About this study
Official title: Clinical Study on the Efficacy of Amide Proton Transfer Magnetic Resonance Imaging in Predicting the Efficacy of Bevacizumab in Recurrent Malignant Gliomas
Targeted therapy with bevacizumab is the main method to prolong the progression-free survival of patients with recurrent malignant gliomas in recent years. Using noninvasive imaging methods to predict which RMG may respond to bevacizumab regimen therapy is a clinical problem ; on the other hand, repeated gadolinium enhancement may increase the risk of gadolinium ion deposition of brain tissue. Furthermore,there may be a false response phenomenon and cause assessment bias.in the evaluation of treatment efficacy,owing to bevacizumab is only anti-tumor angiogenesis.
Amide Proton Transfer (APT) is a new molecular imaging technique. Our previous studies have shown that imaging features and signal changes of APT can fully reflect the therapeutic effect of malignant glioma,without the injection of contrast agent and avoid the side effects.
RMG patients will be recruited in this study . This project will be designed multi-center, prospective, observational clinical research. The changes of APT signal intensity before and after treatment will be compared with those of different types of RMG line. The relationship between APT imaging characteristics and clinical end point events will be investigated and compared with conventional MR imaging technique. The sensitivity, specificity and accuracy of the progression-free survival and median overall survival will be measured after treatment with bevacizumab.
Read the detailed description
Recurrent Malignant Gliomas (RMG) have a very short survival time, and re-operation risk is large and failed to significantly improve the prognosis of patients. At present, targeted therapy with bevacizumab is effective in prolonging the progression of patients However, a considerable proportion of recurrent malignant gliomas are insensitive to bevacizumab, and therefore, using noninvasive imaging methods to predict which RMG is sensitive to bevacizumab therapy prior to targeted therapy is very important On the other hand, the current evaluation of bevacizumab is mainly based on the degree of gadolinium enhancement and tumor volume changes, repeated gadolinium injection may increase the risk of gadolinium ion deposition of brain tissue, and because of Bevacizumab only acting as an anti-tumor angiogenesis, and a false response may occur in assessing efficacy, which is a bias in the overall assessment of bevacizumab.
Amide Proton Transfer (APT) is a new molecular imaging technique for the detection indirect of free protein and peptide concentrations based on chemical saturation exchange. Our previous studies have shown that APT signal is independent of gadolinium-enhanced imaging markers , The signal intensity is closely related to the density of tumor cells, cell proliferation and angiogenesis. Therefore, the imaging features and signal changes of APT can fully reflect the therapeutic effect of malignant glioma, and avoid the side effects caused by contrast injection.
This study will be designed as multi-center, prospective, observational clinical research. 100 cases of RMG patients in Zhujiang Hospital and Nanfang Hospital will be recruited. The patients will be examined with conventional MRI and APT-MRI imaging of 3.0T high field MRI. The treatment of different types of RMG line will be scanned with APT protocol. The changes of signal intensity will be studied. The relationship between APT imaging characteristics and clinical end point events will be observed and compared with conventional MR imaging technique. Two techniques will be used to predict the the 6-month progression-free survival after bevacizumab treatment. The aim of this study is to determine whether APT can predict the efficacy of bevacizumab in the treatment of RMG, and which RMG is effective and sensitive to bevacizumab therapy .Also,we will evaluate the feasibility of APT-MR imaging as a surrogate biomarker for predicting the efficacy of targeted therapy and to establish the basic criteria for the selection of individualized targeted therapy regimens for RMG.
- Conditions
- Diagnoses Disease, Glioma of Brain
- Being tested
- APT MR Imaging
- Keywords
- Amide Proton Transfer, bevacizumab, recurrent malignant gliomas, efficacy
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APT MR ImagingDiagnostic test
Patients who will receive target therapy( Bevacizumab) for recurrent malignant gliomas will obtain routine sequences, Gd- enhanced MR imaging and APT MR imaging will be performed before and after target therapy. We will observe the change of tumor after target therapy using APT imaging. We will compare the change of tumor between Gd-enhanced and APT Imaging before and after therapy.
| Study group | Role | What they receive |
|---|---|---|
| APT MR imaging | Patients who will receive target therapy( Bevacizumab) for recurrent malignant gliomas will be asked to participate in this study. The routine sequences, Gd- enhanced MR imaging and APT MR imaging will be performed before and after target therapy. Receives: Diagnostic Test: APT MR Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal intensity of tumor on APT imaging
Observe the change of signal intensity of tumor on APT MR imaging before and after therapy, determine the predictive value of APT imaging about the efficacy of Bevacizumab in recurrent malignant gliomas.
Measured: From date of confirmed recurrence until the date of deterioration or date of death from any cause. That means measure, assessed APT signal intensity at 6 weeks, 12 weeks,18 weeks and so on, assessed up to 1 year.
Secondary outcomes (1)
Dimension of tumor on Gd-enhanced MRI
Observe the change in dimension of recurrent tumor on Gd-enhanced MRI
Measured: Measure tumor dimension at 6 weeks, 12 weeks and 18 weeks for the most. It will be ended at any time the patient dies.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start3 Jun 2017
- Primary completion30 Sep 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnoses DiseaseStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University
- Responsible party
- Sponsor
- Investigators
- Xiaoxiao Wu, Master, Principal investigator, Institutional Ethics Review Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180697
- Sponsor's protocol ID
- APT MRI and bevacizumab
- Acronym
- APT
- Status last verified
- May 2017
- First submitted
- 11 May 2017
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy of Amide Proton Transfer Magnetic Resonance Imaging in Predicting the Efficacy of Bevacizumab in Recurrent Malignant Gliomas
- ClinicalTrials.gov ID
- NCT03180697
- Acronym / sponsor ID
- APT / APT MRI and bevacizumab
- Conditions
- Diagnoses Disease, Glioma of Brain
- Keywords
- Amide Proton Transfer, bevacizumab, recurrent malignant gliomas, efficacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University
- Study start
- 3 Jun 2017 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 8 Jun 2017 (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.
Targeted therapy with bevacizumab is the main method to prolong the progression-free survival of patients with recurrent malignant gliomas in recent years. Using noninvasive imaging methods to predict which RMG may respond to bevacizumab regimen therapy is a clinical problem ; on the other hand, repeated gadolinium enhancement may increase the risk of gadolinium ion deposition of brain tissue. Furthermore,there may be a false response phenomenon and cause assessment bias.in the evaluation of treatment efficacy,owing to bevacizumab is only anti-tumor angiogenesis.
Amide Proton Transfer (APT) is a new molecular imaging technique. Our previous studies have shown that imaging features and signal changes of APT can fully reflect the therapeutic effect of malignant glioma,without the injection of contrast agent and avoid the side effects.
RMG patients will be recruited in this study . This project will be designed multi-center, prospective, observational clinical research. The changes of APT signal intensity before and after treatment will be compared with those of different types of RMG line. The relationship between APT imaging characteristics and clinical end point events will be investigated and compared with conventional MR imaging technique. The sensitivity, specificity and accuracy of the progression-free survival and median overall survival will be measured after treatment with bevacizumab.
Detailed description
Recurrent Malignant Gliomas (RMG) have a very short survival time, and re-operation risk is large and failed to significantly improve the prognosis of patients. At present, targeted therapy with bevacizumab is effective in prolonging the progression of patients However, a considerable proportion of recurrent malignant gliomas are insensitive to bevacizumab, and therefore, using noninvasive imaging methods to predict which RMG is sensitive to bevacizumab therapy prior to targeted therapy is very important On the other hand, the current evaluation of bevacizumab is mainly based on the degree of gadolinium enhancement and tumor volume changes, repeated gadolinium injection may increase the risk of gadolinium ion deposition of brain tissue, and because of Bevacizumab only acting as an anti-tumor angiogenesis, and a false response may occur in assessing efficacy, which is a bias in the overall assessment of bevacizumab.
Amide Proton Transfer (APT) is a new molecular imaging technique for the detection indirect of free protein and peptide concentrations based on chemical saturation exchange. Our previous studies have shown that APT signal is independent of gadolinium-enhanced imaging markers , The signal intensity is closely related to the density of tumor cells, cell proliferation and angiogenesis. Therefore, the imaging features and signal changes of APT can fully reflect the therapeutic effect of malignant glioma, and avoid the side effects caused by contrast injection.
This study will be designed as multi-center, prospective, observational clinical research. 100 cases of RMG patients in Zhujiang Hospital and Nanfang Hospital will be recruited. The patients will be examined with conventional MRI and APT-MRI imaging of 3.0T high field MRI. The treatment of different types of RMG line will be scanned with APT protocol. The changes of signal intensity will be studied. The relationship between APT imaging characteristics and clinical end point events will be observed and compared with conventional MR imaging technique. Two techniques will be used to predict the the 6-month progression-free survival after bevacizumab treatment. The aim of this study is to determine whether APT can predict the efficacy of bevacizumab in the treatment of RMG, and which RMG is effective and sensitive to bevacizumab therapy .Also,we will evaluate the feasibility of APT-MR imaging as a surrogate biomarker for predicting the efficacy of targeted therapy and to establish the basic criteria for the selection of individualized targeted therapy regimens for RMG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APT MR imaging | – | Diagnostic Test: APT MR ImagingPatients who will receive target therapy( Bevacizumab) for recurrent malignant gliomas will be asked to participate in this study. The routine sequences, Gd- enhanced MR imaging and APT MR imaging will be performed before and after target therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients with recurrent maligant glioma will be recuritted. All the patients are eligible for the inclusive criteria.
Key inclusion criteria (6 listed)
- malignant glioma patients at least 4 weeks after surgery;
- after radiotherapy or chemotherapy after the recurrence, stop to put,
- the age of patients ≥ 18 years old;
- bone marrow, liver and kidney function is good;
- not using steroid hormones or disabled for more than 5 days;
Key exclusion criteria (4 listed)
- patients with refractory hypertension, active vascular disease, bleeding, intestinal perforation and other medical history;
- frail and difficult to tolerate treatment;
- HIV positive;
- pregnant or lactating.
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 |
|---|---|---|
| APT MR ImagingPatients who will receive target therapy( Bevacizumab) for recurrent malignant gliomas will obtain routine sequences, Gd- enhanced MR imaging and APT MR imaging will be performed before and after target therapy. We will observe the change of tumor after target therapy using APT imaging. We will compare the change of tumor between Gd-enhanced and APT Imaging before and after therapy. | Diagnostic test | APT MR imaging |
Primary outcome
Signal intensity of tumor on APT imaging
Time frame: From date of confirmed recurrence until the date of deterioration or date of death from any cause. That means measure, assessed APT signal intensity at 6 weeks, 12 weeks,18 weeks and so on, assessed up to 1 year.
Observe the change of signal intensity of tumor on APT MR imaging before and after therapy, determine the predictive value of APT imaging about the efficacy of Bevacizumab in recurrent malignant gliomas.
1 secondary outcome
Dimension of tumor on Gd-enhanced MRI
Time frame: Measure tumor dimension at 6 weeks, 12 weeks and 18 weeks for the most. It will be ended at any time the patient dies.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Diagnoses Disease
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
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.
Xiaoxiao Wu, Master principal investigator
Institutional Ethics Review Board
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 Diagnoses Disease and Glioma of Brain, run by Zhujiang 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 6 inclusion and 4 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 8 Jun 2017. 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 Zhibo Wen, Doctor (+8613802914951, zhibowen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal intensity of tumor on APT imaging (time frame: From date of confirmed recurrence until the date of deterioration or date of death from any cause. That means measure, assessed APT signal intensity at 6 weeks, 12 weeks,18 weeks and so on, assessed up to 1 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 8 Jun 2017.