BBPA PET/CT in Patients With Malignant Tumors

Safety and Clinical Value of 18Fluorine-labeled BBPA PET/CT in Patients With Malignant Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Tumors
• Intervention / Treatment: Diagnostic test: BBPA PET examination

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

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 10005
      • Recruiting
      • Wenbin Ma
      • Contact: Wenbin Ma, M.D.; Phone Number: +8613701364566; Email: mawb2001@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Malignant Tumors; BBPA in suspected malignant tumors. This arm investigates the metabolic characteristics of BBPA in suspected malignant tumor patients who consider for surgical operations. A single dose of 0.10 mCi/kg BBPA will be intravenously injected and PET examination will carry out 30 minutes later. Surgical operations, if recommended after multiple examination, will be carried out within 1 week after BBPA PET scan.

Diagnostic test: BBPA PET examination; A single dose of 0.10 mCi/kg BBPA will be intravenously injected and PET examination will carry out 30 minutes later.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
standardized uptake value (SUV) for BBPA	SUV reflects the uptake of PET tracers, and quantitative imaging features such as SUVmax, SUVmean, and visually assessed features will be measured in the evaluation of tumors.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse event within 1 week after BBPA injection will be documented.	1 week

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Peking University; Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: August 3, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: malignant tumors; BBPA-PET/CT
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: PekingUMCH-BBPA PET/CT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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