Solid TumorNCT07450560
Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET
An observational study of Solid Tumor, run by Shuanghu Yuan at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- proton therapy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 31 Dec 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with solid tumors scheduled to receive proton therapy, with measurable lesions;
Who may be able to join
- Patients with solid tumors scheduled to receive proton therapy, with measurable lesions;
- Signed the informed consent form.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Full-Digital PET Enables Real-time Monitoring of Proton Range
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.
- Conditions
- Solid Tumor
- Being tested
- proton therapy
- Keywords
- Proton Therapy, fully digital PET, in-beam online monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proton therapyRadiation
proton therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Feb 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Shuanghu Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shuanghu Yuan, Anhui Provincial Cancer Hospital
- Investigators
- Xiaojing Wang, MD, Study chair, Anhui Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450560
- Sponsor's protocol ID
- CRTOG2602
- Status last verified
- Mar 2026
- First submitted
- 21 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full-Digital PET Enables Real-time Monitoring of Proton Range
- ClinicalTrials.gov ID
- NCT07450560
- Acronym / sponsor ID
- CRTOG2602
- Conditions
- Solid Tumor
- Keywords
- Proton Therapy, fully digital PET, in-beam online monitoring
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shuanghu YuanUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with solid tumors scheduled to receive proton therapy, with measurable lesions;
Key inclusion criteria (2 listed)
- Patients with solid tumors scheduled to receive proton therapy, with measurable lesions;
- Signed the informed consent form.
Key exclusion criteria (2 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| proton therapyproton therapy | Radiation | – |
Primary outcome
the trajectory and range of the proton beam within the human body
Time frame: 1 day
the three-dimensional dynamic distribution of positron nuclides generated by proton beam irradiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Solid Tumor
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaojing Wang, MD study chair
Anhui Provincial Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor, run by Shuanghu Yuan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the trajectory and range of the proton beam within the human body (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.