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Trial Title:
BBPA PET/CT in Patients With Malignant Tumors
NCT ID:
NCT05987098
Condition:
Malignant Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
malignant tumors
BBPA-PET/CT
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
A single dose of BBPA will be intravenously injected and PET examination will carry out
30 minutes later.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
BBPA PET examination
Description:
A single dose of 0.10 mCi/kg BBPA will be intravenously injected and PET examination will
carry out 30 minutes later.
Arm group label:
Malignant Tumors
Summary:
This study is an open-labeled phase II diagnostic clinical trial to explore the safety
and clinical value of BBPA-PET/CT in suspected malignant tumor patients. The
investigation regarding the clinical value of BBPA concerning the metabolic
characteristics of BBPA in suspected malignant tumors. Quantitative features will be
extracted to analysis the PET images. For patient who took surgery after multiple
examination, histopathology, molecular pathology and LAT-1 immunohistochemistry will also
be obtained.
Detailed description:
In this study, we utilized BBPA, a novel boron amino acid, which replaces the carboxyl
group of 4-boronate phenylalanine (BPA) with a boron trifluoride group (-BF3) (-COOH), as
a diagnostic molecule for PET imaging of brain tumors, is also a highly efficient boron
carrier for BNCT. Preclinical studies suggested [18F]BBPA to be a pan-cancer probe that
transmembrane transported through large neutral amino acid transporter type-1 (LAT-1).
However more studies and evidence are warranted to investigate the clinical value of BBPA
PET imaging in human.
This study aim to observe the safety of BBPA, and investigate the diagnostic value of
BBPA in the patient with suspected malignant 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, BBPA 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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Have suspected diagnosis of brain tumors, based on clinical performance and imaging
results.
- Meet the indications for PET examination, show a clear indication and no
contraindications;
- Have a performance status of score ≥80 on KPS scale or score 0-1 points on ECOG
scale, a relatively good general situation;
- 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;
- Be ≥ 18 years of age on day of signing informed consent.
- Be willing and able to understand the research content and provide written informed
consent/assent for the trial.
Exclusion Criteria:
- Have a history of imaging agent allergies;
- Does not meet the PET-CT scan sedation requirements, or there are contraindications
for PET-CT examination;
- Be pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial;
- Unable to adhere strictly to protocol requirements.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Wenbin Ma
Address:
City:
Beijing
Zip:
10005
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenbin Ma, M.D.
Phone:
+8613701364566
Email:
mawb2001@hotmail.com
Start date:
March 22, 2021
Completion date:
September 1, 2024
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
Peking University
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05987098
