Research on Real-time Proton Therapy Guidance Through Mon... | NCT07450560

Studies
Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET

NCT07450560

Sponsor

Shuanghu Yuan

Status

Active, not recruiting

Last Update Posted

Mar 10, 2026Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Solid Tumor

Interventions

proton therapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2026Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Feb 21, 2026

First Submission Date that Met QC Criteria

Feb 26, 2026

First Posted Date

Mar 4, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2026

Last Update Posted Date

Mar 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Name	Type	Description	Arm Group Labels	Other Names
proton therapy	Radiation	proton therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiaojing Wang, MD	Anhui Provincial Cancer Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anhui Provincial Hospital		Hefei	Anhui	230001	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Types

Study Protocol

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D061766	Proton Therapy

Ancestor Terms

ID	Term
D063193	Heavy Ion Radiotherapy
D011878	Radiotherapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided