To hear about similar clinical trials, please enter your email below
Trial Title:
Fluoride-labeled Boronophenylalanine PET Imaging in Patients With Solid Tumors
NCT ID:
NCT05538676
Condition:
Solid Tumor, Adult
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
solid tumor BPA-PET
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
BPA-PET imaging
Description:
PET imaging
Summary:
Recently, new high-dose radiation therapy [e.g., boron neutron capture therapy (BNCT)]
absorbed into the tumor tissue has been applied to treat patients with solid tumors. Here
we examine and describe how to evaluate the biological activity of tumors using positron
emission tomography (PET) with fluoride-labeled boronophenylalanine (F-BPA) as a tracer.
Detailed description:
Boron Neutron Capture Therapy（BNCT） is an advanced cell-scale binary targeted
radiotherapy technology that combines the advantages of targeted therapy and heavy ion
therapy. BNCT provides a neutron source from a reactor or a medical accelerator. At the
same time, the patient needs to be pre-injected with a boron-containing drug containing a
non-radioactive boron 10 isotope. The boron drug enters the body and accumulates
specifically in cancer cells. The patient receives epithermal neutron beam irradiation
with high linear energy transfer (Linear EnergyTransferLET), thereby achieving the effect
of killing tumor cells. Purpose，BNCT has more advantages over conventional radiotherapy,
and normal tissue is better preserved than conventional radiotherapy.
PET imaging is a useful and effective technique to give absolute quantitative and
biological distribution data of BPA in a non-invasive manner, and can add important
characteristic parameters such as T/N ratio, SUV and Kinetic parameters. Given the
complexity of BNCT, PET and PET/CT is currently the new standard for designing patient
recruitment: The Methodology of L-18F-BPA PET is an important tool to design clinical
trials , estimate the size of tumor and indicate the concentration ratio of BPA in
surrounding normal tissues. Following this principle, researchers can accurately identify
which patients can benefit from BNCT treatment through the selective accumulation of BPA
in individual tumors. PET scans can provide a three-dimensional map of the boron
distribution, which can be used for macroscopic dose calculations in the BNCT
conventional neutron transmission code. Because most of the dose absorbed by living cells
(65%) comes from the 10B(n,a)7Li response, the distribution of boron determines the
variability of the main absorbed dose in the treatment plan. As a result, therapeutic
schedule will be improved because the boron distribution will greatly affect the isodose
line. Routine calculations provide a wider range of isodose contours, whereas PET
produces contours that more closely approximate the observed clinical results of BNCT.
Criteria for eligibility:
Study pop:
patients with diagnosed solid tumor
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- patients with clinically diagnosed solid tumors, including but not limited to
recurrent head and neck cancer, glioma, pancreatic cancer, osteosarcoma, etc.; The
selected subjects need to sign the informed consent.
Exclusion Criteria:
- Pregnant women; renal failure (serum Cr>3mg/dl); Patients with claustrophobia;
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
TongjiHospital
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Recruiting
Contact:
Last name:
xiaohua zhu, Dr.
Phone:
13971513770
Phone ext:
86
Email:
evazhu@vip.sina.com
Start date:
December 26, 2022
Completion date:
August 25, 2025
Lead sponsor:
Agency:
Xiaohua Zhu
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05538676
