BBPA PET/CT in Patients With Malignant Tumors

NCT05987098 | Recruiting

• 1 other identifier: PekingUMCH-BBPA PET/CT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Tumors

Keywords

malignant tumors; BBPA-PET/CT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse events

  1 week

Study Arms (1)

Malignant Tumors

EXPERIMENTAL

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

Interventions

BBPA PET examination DIAGNOSTIC_TEST

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

Malignant Tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Peking University: collaborator
• Peking University Cancer Hospital & Institute: collaborator

Study Sites (1)

Wenbin Ma

Beijing, Beijing Municipality, 10005, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single dose of BBPA will be intravenously injected and PET examination will carry out 30 minutes later.

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: March 22, 2021
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)