Fluoride-labeled Boronophenylalanine PET Imaging in Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT05538676

Recruitment Status  : Not yet recruiting

First Posted  : September 14, 2022
Last Update Posted  : October 20, 2022

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Sponsor:
Tongji Hospital

Information provided by (Responsible Party):

Tongji Hospital

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Study Description Go to 

Brief 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.

Condition or disease  Intervention/treatment 

 Solid Tumor, Adult Diagnostic Test: BPA-PET imaging

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.
Study Design Go to 

Study Type  :
Observational

Estimated Enrollment  :
10 participants

Observational Model:
Other

Time Perspective:
Prospective

Official Title:
Fluoride-labeled Boronophenylalanine PET Imaging in Patients With Solid Tumors

Estimated Study Start Date  :

December 25, 2022

Estimated Primary Completion Date  :

August 25, 2023

Estimated Study Completion Date  :

August 25, 2025
 Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diagnostic Imaging

U.S. FDA Resources

Groups and Cohorts Go to 

Intervention Details:

Diagnostic Test: BPA-PET imaging

PET imaging

Outcome Measures Go to 

Primary Outcome Measures  :

1. TBR（Tumor-to-Backgroud Ratio） [ Time Frame: 1 year ]

We delineate the region of interest (ROI), obtain the maximum standard uptake value (SUVmax) of
the ROI in the PET/CT images. The target-to-background ratio (TBR) of the lesion was calculated.

Eligibility Criteria Go to 

Information from the National Library of Medicine

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Ages Eligible for Study:  

18 Years to 80 Years   (Adult, Older Adult)

Sexes Eligible for Study:  

All

Accepts Healthy Volunteers:  

No

Sampling Method:  
Probability Sample

Study Population
patients with diagnosed solid tumor

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;

Contacts and Locations Go to 

No Contacts or Locations Provided

More Information Go to 

Responsible Party:
Tongji Hospital

ClinicalTrials.gov Identifier:
NCT05538676     History of Changes

Other Study ID Numbers:

2022S150

First Posted:
September 14, 2022    Key Record Dates

Last Update Posted:

October 20, 2022

Last Verified:
August 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

No

Studies a U.S. FDA-regulated Device Product:

No

Keywords provided by Tongji Hospital:

solid tumor BPA-PET
Additional relevant MeSH terms:
Neoplasms