GlioblastomaEarly Phase 1NCT02910804
IRDye800CW-BBN PET-NIRF Imaging Guiding Surgery in Patients With Glioblastoma
A Early Phase 1 study testing 68Ga-BBN-IRDye800CW, PET/NIRF and PET/NIR fluorescent imaging-guided surgery in people with Glioblastoma, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This is an open-label positron emission tomography/near infrared (PET/NIRF) study to investigate the imaging navigation performance and evaluation efficacy of dual modality imaging probe 68Ga-BBN-IRDye800CW in glioblastoma (GBM) patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glioblastoma
- What is being tested?
- 68Ga-BBN-IRDye800CW, PET/NIRF and PET/NIR fluorescent imaging-guided surgery
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Dec 2018
- Phase
- Early Phase 1
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be able to provide a written informed consent
- MRI imaging and/or pathological evidence of Newly Diagnosed or recurrence GBM
Who cannot join
- Consisted of conditions of mental illness
- Severe liver or kidney disease with serum creatinine > 3.0 mg/dl (270 μΜ)
- Any hepatic enzyme level 5 times or more than normal upper limit
- Severe allergy or hypersensitivity to IV radiographic contrast
- Claustrophobia to accept the PET/CT scanning
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
Deling Li, MD contact
Jingjing Zhang, MD. contact
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Deling Li, MD., +86 10 69154196, ttyyneuroli@126.com
About this study
Official title: PET-NIRF Dual Modality Imaging Guiding Surgery in Patients With Glioblastoma
This is an open-label positron emission tomography/near infrared (PET/NIRF) study to investigate the imaging navigation performance and evaluation efficacy of dual modality imaging probe 68Ga-BBN-IRDye800CW in glioblastoma (GBM) patients. A single dose of 40μg/111-148 Mega-Becquerel (MBq) and 1.0 mg/ml 68Ga-BBN-IRDye800CW will be injected intravenously before the operation and intraoperative respectively. Visual and semiquantitative method will be used to assess the PET images and real-time margins localization for surgical navigation.
Read the detailed description
Non-invasive preoperative PET imaging evaluation and real-time fluorescence-guided surgery would be of great help in GBM patients. BBN, with the amino acid sequence of Gln-Trp-Ala-Val-Gly-His-Leu-Met-NH2, has been extensively used for the development of molecular probes for the imaging of gastrin-releasing peptide receptor (GRPR), a member of the G protein-coupled receptor family of bombesin receptors that over-expressed in various types of cancer cells including glioblastoma multiforme. For interests in clinical translation of GRPR targeting dual modality probe, an open label dual modality imaging PET/ NIFR study was designed to investigate the safety and imaging guiding performance of 68Ga-BBN-IRDye800CW in patients with GBM.
- Conditions
- Glioblastoma
- Being tested
- 68Ga-BBN-IRDye800CW, PET/NIRF, PET/NIR fluorescent imaging-guided surgery
- Keywords
- GBM, GRPR, IRDye800, NIRF, surgery
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-BBN-IRDye800CWDrug
Also called BBN-IRDye800CW
PET/NIRFDevice
Also called Positron emission tomography/Near-infrared fluorescent
PET/NIR fluorescent imaging-guided surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-BBN-IRDye800CW PET/NIRF | Experimental | The patients were injected with 40μg/111-148 Mega-Becquerel (MBq) 68Ga-BBN-IRDye800CW in one dose intravenously and then underwent PET scan 30 min later before the operation and intraoperative 1.0 mg/ml BBN-IRDye800CW injected intravenously for near-infrared (NIR) fluorescent imaging-guided surgery. Receives: Drug: 68Ga-BBN-IRDye800CW; Device: PET/NIRF; Procedure: PET/NIR fluorescent imaging-guided surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value of 68Ga-BBN-IRDye800CW in PET imaging of GBM
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in GBM will be measured.
Measured: 1 year
Margin assessment of positive tumors in NIRF fluorescent-guided surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startNov 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, National Institute for Biomedical Imaging and Bioengineering (NIBIB), Chinese Academy of Sciences
- Responsible party
- Principal investigator, Deling Li, Beijing Tiantan Hospital
- Investigators
- Nan Ji, MD, Study director, Beijing Tiantan Hospital, Capital Medical University Beijing 100050, ChinaZhaohui Zhu, MD., Study director, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910804
- Sponsor's protocol ID
- BTHospital-N-005
- Other IDs
- ZIAEB000073
- Status last verified
- Jan 2018
- First submitted
- 16 Sep 2016
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET-NIRF Dual Modality Imaging Guiding Surgery in Patients With Glioblastoma
- ClinicalTrials.gov ID
- NCT02910804
- Acronym / sponsor ID
- BTHospital-N-005
- Conditions
- Glioblastoma
- Keywords
- GBM, GRPR, IRDye800, NIRF, surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, National Institute for Biomedical Imaging and Bioengineering (NIBIB), Chinese Academy of Sciences
- Study start
- Nov 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 Sep 2016 (estimated)
- 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 an open-label positron emission tomography/near infrared (PET/NIRF) study to investigate the imaging navigation performance and evaluation efficacy of dual modality imaging probe 68Ga-BBN-IRDye800CW in glioblastoma (GBM) patients. A single dose of 40μg/111-148 Mega-Becquerel (MBq) and 1.0 mg/ml 68Ga-BBN-IRDye800CW will be injected intravenously before the operation and intraoperative respectively. Visual and semiquantitative method will be used to assess the PET images and real-time margins localization for surgical navigation.
Detailed description
Non-invasive preoperative PET imaging evaluation and real-time fluorescence-guided surgery would be of great help in GBM patients. BBN, with the amino acid sequence of Gln-Trp-Ala-Val-Gly-His-Leu-Met-NH2, has been extensively used for the development of molecular probes for the imaging of gastrin-releasing peptide receptor (GRPR), a member of the G protein-coupled receptor family of bombesin receptors that over-expressed in various types of cancer cells including glioblastoma multiforme. For interests in clinical translation of GRPR targeting dual modality probe, an open label dual modality imaging PET/ NIFR study was designed to investigate the safety and imaging guiding performance of 68Ga-BBN-IRDye800CW in patients with GBM.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-BBN-IRDye800CW PET/NIRF | Experimental | Drug: 68Ga-BBN-IRDye800CW, Device: PET/NIRF, Procedure: PET/NIR fluorescent imaging-guided surgeryThe patients were injected with 40μg/111-148 Mega-Becquerel (MBq) 68Ga-BBN-IRDye800CW in one dose intravenously and then underwent PET scan 30 min later before the operation and intraoperative 1.0 mg/ml BBN-IRDye800CW injected intravenously for near-infrared (NIR) fluorescent imaging-guided surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be able to provide a written informed consent
- MRI imaging and/or pathological evidence of Newly Diagnosed or recurrence GBM
Key exclusion criteria (6 listed)
- Consisted of conditions of mental illness
- Severe liver or kidney disease with serum creatinine > 3.0 mg/dl (270 μΜ)
- Any hepatic enzyme level 5 times or more than normal upper limit
- Severe allergy or hypersensitivity to IV radiographic contrast
- Claustrophobia to accept the PET/CT scanning
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-BBN-IRDye800CWAlso: BBN-IRDye800CW | Drug | 68Ga-BBN-IRDye800CW PET/NIRF |
| PET/NIRFAlso: Positron emission tomography/Near-infrared fluorescent | Device | 68Ga-BBN-IRDye800CW PET/NIRF |
| PET/NIR fluorescent imaging-guided surgery | Procedure or surgery | 68Ga-BBN-IRDye800CW PET/NIRF |
Primary outcome
Standardized uptake value of 68Ga-BBN-IRDye800CW in PET imaging of GBM
Time frame: 1 year
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in GBM will be measured.
Margin assessment of positive tumors in NIRF fluorescent-guided surgery
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
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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.
Deling Li, MD contact
Jingjing Zhang, MD. contact
Nan Ji, MD study director
Beijing Tiantan Hospital, Capital Medical University Beijing 100050, China
Zhaohui Zhu, MD. study director
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 68Ga-BBN-IRDye800CW, PET/NIRF and PET/NIR fluorescent imaging-guided surgery in people with Glioblastoma, run by Beijing Tiantan 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 2 inclusion and 6 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 18 Jan 2018. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Deling Li, MD (ttyyneuroli@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value of 68Ga-BBN-IRDye800CW in PET imaging of GBM (time frame: 1 year). 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 18 Jan 2018.