FBY PET/CT in Patients With Brain Tumors
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03980431 |
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Recruitment Status :
Recruiting
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Brain Tumor | Diagnostic Test: FBY-PET Examination Group: Patients receive FBY-PET examination after entrance | Not Applicable |
FBY is a new PET tracer derived from tyrosine, with the carboxyl group replaced by boron trifluoride, and is transferred across cell membrane through LAT-1. LAT-1 is a sodium independent amino acid transporter and is highly expressed in tumor cells. Considering the significant role in cancer development as well as in nutrient delivery, FBY could be a promising PET tracer to reflect altered metabolism in tumors.
This study aim to observe the safety of FBY, and investigate the diagnostic, prognostic, predictive performance of FBY in the patient with suspected brain tumors. Patients who meet the eligibility criteria are included in clinical trials after fully communicating the condition, explaining the benefits and risks of clinical trials, clarifying the patient's willingness to include the clinical trial, and signing informed consent. The cohort number, FBY administrative dose, imaging protocols are decided based on the investigators' preliminary data. The diagnosis and post-examination treatment are based on the recommended guideline, combined with the subject's own situation for standardized diagnosis and treatment.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | A single dose of 0.15 mCi/kg FBY will be intravenously injected and PET examination will carry out 30 minutes later. |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Safety and Clinical Value of 18Fluorine-labeled Boron Tyrosine PET/CT in Patients With Brain Tumors |
| Actual Study Start Date : | January 1, 2019 |
| Estimated Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | December 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: FBY-PET Group |
Diagnostic Test: FBY-PET Examination Group: Patients receive FBY-PET examination after entrance
A single dose of 0.15 mCi/kg FBY will be intravenously injected and PET examination will carry out 30 minutes later. |
- standardized uptake value (SUV) for FBY [ Time Frame: 1 week. ]SUV reflects the uptake of PET tracers, and quantitative imaging features such as SUVmax, SUVmean, and visually-assessed features will be measured in the evaluation of tumors.
- Adverse events [ Time Frame: 1 week. ]Adverse event within 1 week after FBY injection will be documented.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 1. Have suspected diagnosis of brain tumors, based on clinical performance and MRI results.
- 2. Meet the indications for PET examination, show a clear indication and no contraindications;
- 3. Have a performance status of score >80 on KPS scale or score 0-1 points on ECOG scale, a relatively good general situation;
- 4 Does not appear agonal stage, deep coma, over grade 2 major organ dysfunction (heart, lung, liver, kidney and other major organ include), acute or life-threatening status of infection;
- 5. Be > 18 years of age on day of signing informed consent.
- 6. Be willing and able to understand the research content and provide written informed consent/assent for the trial.
Exclusion Criteria:
- 1. Have a history of imaging agent allergies;
- 2. Does not meet the PET-CT scan sedation requirements, or there are contraindications for PET-CT examination;
- 3. Be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial;
- 4. Unable to adhere strictly to protocol requirements.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980431
| China, Beijing | |
| Wenbin Ma | Recruiting |
| Beijing, Beijing, China, 100005 | |
| Contact: Wenbin Ma, M.D. +8613701364566 mawb2001@hotmail.com | |
| Contact: Yu Wang, M.D. +8615311860318 ywang@pumch.cn | |
Publications:
| Responsible Party: | Peking Union Medical College Hospital |
| ClinicalTrials.gov Identifier: | NCT03980431 History of Changes |
| Other Study ID Numbers: |
PekingUMCH-FBY PET/CT |
| First Posted: | June 10, 2019 Key Record Dates |
| Last Update Posted: | June 10, 2019 |
| Last Verified: | June 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Peking Union Medical College Hospital:
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Brain Tumor FBY-Positron Emission Computed Tomography (FBY-PET) glioma brain metastasis |
Additional relevant MeSH terms:
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Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site |
Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases |