NCT05538676

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

December 26, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2025

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

August 24, 2022

Last Update Submit

February 9, 2023

Conditions

Solid Tumor, Adult

Keywords

solid tumor BPA-PET

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

BPA-PET imagingDIAGNOSTIC_TEST

PET imaging

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with diagnosed solid tumor

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant women; renal failure (serum Cr\>3mg/dl); Patients with claustrophobia;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TongjiHospital

Wuhan, Hubei, 430030, China

RECRUITING

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 24, 2022

First Posted

September 14, 2022

Study Start

December 26, 2022

Primary Completion

August 25, 2023

Study Completion

August 25, 2025

Last Updated

February 13, 2023

Record last verified: 2023-02

Locations

CN(1)