Fluoride-labeled Boronophenylalanine PET Imaging in Patients With Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • TongjiHospital
      • Contact: xiaohua zhu, Dr.; Phone Number: 86 13971513770; Email: evazhu@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with diagnosed solid tumor

Description

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;

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TBR（Tumor-to-Backgroud Ratio）	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.	1 year

Collaborators and Investigators

• Sponsor: Xiaohua Zhu

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 26, 2022
• Primary Completion (ANTICIPATED): August 25, 2023
• Study Completion (ANTICIPATED): August 25, 2025

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (ACTUAL): September 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: solid tumor BPA-PET
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2022S150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No