Fluoride-labeled Boronophenylalanine PET Imaging in Patients With Solid Tumors

NCT ID: NCT05538676

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-26
• Study Completion Date: 2025-08-25

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.

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.

Conditions

Solid Tumor, Adult

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

BPA-PET imaging

PET imaging

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiaohua Zhu

OTHER

Sponsor Role: lead

Responsible Party

Xiaohua Zhu

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

TongjiHospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Facility Contacts

xiaohua zhu, Dr.

Role: primary

evazhu@vip.sina.com

13971513770 ext. 86

Other Identifiers

2022S150

Identifier Type: -

Identifier Source: org_study_id