GliomaPhase 1NCT03407781
IRDye800CW-BBN PET-NIRF Imaging Guiding Surgery in Patients With Lower Grade Glioma
A Phase 1 study testing 68Ga-BBN-IRDye800CW in people with Glioma, run by Deling Li 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 patients with lower grade glioma. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glioma
- What is being tested?
- 68Ga-BBN-IRDye800CW
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 17 Aug 2018
- Phase
- 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
- suspected lower grade gliomas on contrast-enhanced MRI
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 or PET/MRI scanning
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IRDye800CW-BBN PET-NIRF in Lower Grade Glioma
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 patients with lower grade glioma. A single dose of 40μg/111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN and 1.0- or 2.0- mg/ml IRDye800CW-BBN 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
Lower grade gliomas (WHO grades II and III) are currently diffused disease with variability of tumor behaviors and of challenge to distinguish the margins in white-light microscope during the surgery. An integrated dual-modality approach combining preoperative positron emission tomography imaging with intraoperative optical guidance that target the same tumor biomarker would be of grade help to solve this problem. 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 glioma. For interests in clinical translation of GRPR targeting dual modality probe, an open label dual modality imaging PET/ NIRF study was designed to investigate the imaging guiding performance in lower grade glioma patients. To investigate whether the preoperative PET with BBN can predict the success of the fluorescence guided surgery with same peptide intraoperatively. The sensitivity, specificity and accuracy of fluorescence guided sampling intraoperatively according to the final pathology will be assessed as well.
- Conditions
- Glioma
- Being tested
- 68Ga-BBN-IRDye800CW
- Keywords
- fluorescence guided surgery; dual-modality imaging
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-BBN-IRDye800CWDrug
Also called IRDye800CW-BBN
PET/NIR fluorescent imaging-guided 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 or 2.0 mg/ml BBN-IRDye800CW injected intravenously for near-infrared (NIR) fluorescent imaging-guided surgery. Receives: Drug: 68Ga-BBN-IRDye800CW |
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 lower grade gliomas
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in lower grade glioma will be measured.
Measured: 1 year
Secondary outcomes (1)
The sensitivity and specificity of intraoperative IRDye800CW-BBN fluorescence
The sensitivity and specificity of intraoperative IRDye800CW-BBN fluorescence, and the preoperative PET and MRI imaging indicator for IRDye800CW-BBN fluorescence imaging in lower grade gliomas
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 posted23 Jan 2018
- Study start1 Jan 2016
- Primary completion17 Aug 2018
- Study completion17 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In the first stage, a small proportion of participants receive preoperative 68Ga-IRDye800-BBN PET/CT and then
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deling Li
- 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
- Sponsor-investigator, Deling Li, Beijing Tiantan Hospital
- Investigators
- Zhaohui Zhu, MD, Study director, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeNan Ji, MD, Study director, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407781
- Sponsor's protocol ID
- BTHospital-N-008
- Other IDs
- ZIAEB000073
- Status last verified
- Aug 2024
- First submitted
- 16 Jan 2018
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IRDye800CW-BBN PET-NIRF in Lower Grade Glioma
- ClinicalTrials.gov ID
- NCT03407781
- Acronym / sponsor ID
- BTHospital-N-008
- Conditions
- Glioma
- Keywords
- fluorescence guided surgery; dual-modality imaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Deling LiUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, National Institute for Biomedical Imaging and Bioengineering (NIBIB), Chinese Academy of Sciences
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 17 Aug 2018 (actual)
- Study completion
- 17 Aug 2018 (actual)
- First posted
- 23 Jan 2018 (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 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 patients with lower grade glioma. A single dose of 40μg/111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN and 1.0- or 2.0- mg/ml IRDye800CW-BBN 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
Lower grade gliomas (WHO grades II and III) are currently diffused disease with variability of tumor behaviors and of challenge to distinguish the margins in white-light microscope during the surgery. An integrated dual-modality approach combining preoperative positron emission tomography imaging with intraoperative optical guidance that target the same tumor biomarker would be of grade help to solve this problem. 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 glioma. For interests in clinical translation of GRPR targeting dual modality probe, an open label dual modality imaging PET/ NIRF study was designed to investigate the imaging guiding performance in lower grade glioma patients. To investigate whether the preoperative PET with BBN can predict the success of the fluorescence guided surgery with same peptide intraoperatively. The sensitivity, specificity and accuracy of fluorescence guided sampling intraoperatively according to the final pathology will be assessed as well.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In the first stage, a small proportion of participants receive preoperative 68Ga-IRDye800-BBN PET/CT and then
| Arm | Type | Receives |
|---|---|---|
| 68Ga-BBN-IRDye800CW PET/NIRF | Experimental | Drug: 68Ga-BBN-IRDye800CWThe 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 or 2.0 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
- suspected lower grade gliomas on contrast-enhanced MRI
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 or PET/MRI 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: IRDye800CW-BBNPET/NIR fluorescent imaging-guided surgery | Drug | 68Ga-BBN-IRDye800CW PET/NIRF |
Primary outcome
Standardized uptake value of 68Ga-BBN-IRDye800CW in PET imaging of lower grade gliomas
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 lower grade glioma will be measured.
1 secondary outcome
The sensitivity and specificity of intraoperative IRDye800CW-BBN fluorescence
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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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.
Zhaohui Zhu, MD study director
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Nan Ji, MD study director
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 68Ga-BBN-IRDye800CW in people with Glioma, run by Deling Li 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: finished, as of the sponsor's last update on 6 Aug 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 lower grade gliomas (time frame: 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 6 Aug 2024.