NCT07450560

Brief Summary

The energy transport process of proton beams after entering biological tissue is observed online via proton knife fully digital PET. The dynamic changes of the delivered dose and action range of proton beams in biological tissue are analyzed, the proton dose distribution is reconstructed, and the energy and position of the targeted ablation by proton beams are determined, so as to realize in-beam online PET monitoring for proton therapy.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
29mo left

Started Feb 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress18%
Feb 2026Dec 2028

Study Start

First participant enrolled

February 1, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

February 21, 2026

Last Update Submit

March 7, 2026

Conditions

Keywords

Proton Therapyfully digital PETin-beam online monitoring

Outcome Measures

Primary Outcomes (1)

  • the trajectory and range of the proton beam within the human body

    the three-dimensional dynamic distribution of positron nuclides generated by proton beam irradiation

    1 day

Interventions

proton therapy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with solid tumors scheduled to receive proton therapy, with measurable lesions;

You may qualify if:

  • Patients with solid tumors scheduled to receive proton therapy, with measurable lesions;
  • Signed the informed consent form.

You may not qualify if:

  • Patients with a history of radioactive seed implantation;
  • Patients who cannot understand the purpose of treatment or are unwilling/unable to sign the informed consent form;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

Location

MeSH Terms

Interventions

Proton Therapy

Intervention Hierarchy (Ancestors)

Heavy Ion RadiotherapyRadiotherapyTherapeutics

Study Officials

  • Xiaojing Wang, MD

    Anhui Provincial Cancer Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 21, 2026

First Posted

March 4, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

The energy transport process of proton beams after entering biological tissue is observed online via proton knife fully digital PET. The dynamic changes of the delivered dose and action range of proton beams in biological tissue are analyzed, the proton dose distribution is reconstructed, and the energy and position of the targeted ablation by proton beams are determined, so as to realize in-beam online PET monitoring for proton therapy.

Shared Documents
STUDY PROTOCOL

Locations