Glioblastoma Multiforme (GBM)NCT06939400
Photodynamic Therapy for Glioblastoma Multiforme Based on Metaverse and Yellow Fluorescence
An observational study of Glioblastoma Multiforme (GBM), run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial summary
GBM patients receiving PDT treatment (50 cases，surgery combined with photodynamic therapy) and traditional treatment (50 cases，traditional surgery) in our hospital and partner hospitals were collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme (GBM)
- What is being tested?
- Photodynamic therapy (PDT) and GBM patients recevied traditional treatment options
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: GBM patients recevied traditional treatment options (including surgery combined with radiotherapy and chemotherapy) or PDT treatment
Who may be able to join
- Pathologically confirmed primary focal GBM; Recurrent GBM(single or satellite lesions); Multiple (multiple germinal centers)GBM.
Who cannot join
- Photosensitizer allergy.
- Severe coagulation disorder.
- Patients with severe cardiovascular and cerebrovascular diseases, especially patients in the acute stage.
- Multiple organ failure, end-stage patients. ⑤ Pregnant women: Photofrin is considered a class C pregnancy risk (toxic, non-teratogenic) drug with non-dialysis properties.
- Non-gbm diagnosis: Patients with other types of brain tumors or diseases. 7 Do not agree to informed consent: patients who are unwilling to sign informed consent or do not agree to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Yi Yuan, Doctor, 0571-85893451, zjsrmyykyb@163.com
About this study
Official title: Study on Precision Photodynamic Therapy for Glioblastoma Multiforme Based on Metaverse and Yellow Fluorescence
GBM patients receiving PDT treatment (50 cases，surgery combined with photodynamic therapy) and traditional treatment (50 cases，traditional surgery) in our hospital and partner hospitals were collected. The prognosis was analyzed by comparing with the control group from multiple perspectives such as image evaluation, imaging effect, Karnofsky score, median survival time and survival rate.
- Conditions
- Glioblastoma Multiforme (GBM)
- Being tested
- Photodynamic therapy (PDT), GBM patients recevied traditional treatment options
- Keywords
- Glioblastoma Multiforme, photodynamic therapy, metaverse, yellow fluorescence
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic therapy (PDT)Procedure or surgery
Also called Surgical combination photodynamic therapy
GBM patients recevied surgical combination photodynamic therapy
GBM patients recevied traditional treatment optionsProcedure or surgery
GBM patients recevied traditional treatment options (including surgery combined with radiotherapy and chemotherapy)
| Study group | Role | What they receive |
|---|---|---|
| Control | GBM patients recevied traditional treatment options (including surgery combined with radiotherapy and chemotherapy) Receives: Procedure: GBM patients recevied traditional treatment options | |
| Treatment | GBM patients recevied surgical combination photodynamic therapy Receives: Procedure: Photodynamic therapy (PDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment of Surgical combination Photodyanmic therapy
Measured: From June 2025 to June 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma Multiforme (GBM)Studies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Harbin Medical University
- Responsible party
- Principal investigator, Hushaoshan, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939400
- Sponsor's protocol ID
- KY2024208
- Status last verified
- Jan 2025
- First submitted
- 10 Feb 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Precision Photodynamic Therapy for Glioblastoma Multiforme Based on Metaverse and Yellow Fluorescence
- ClinicalTrials.gov ID
- NCT06939400
- Acronym / sponsor ID
- KY2024208
- Conditions
- Glioblastoma Multiforme (GBM)
- Keywords
- Glioblastoma Multiforme, photodynamic therapy, metaverse, yellow fluorescence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Harbin Medical University
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Apr 2025 (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.
GBM patients receiving PDT treatment (50 cases，surgery combined with photodynamic therapy) and traditional treatment (50 cases，traditional surgery) in our hospital and partner hospitals were collected. The prognosis was analyzed by comparing with the control group from multiple perspectives such as image evaluation, imaging effect, Karnofsky score, median survival time and survival rate.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Procedure: GBM patients recevied traditional treatment optionsGBM patients recevied traditional treatment options (including surgery combined with radiotherapy and chemotherapy) |
| Treatment | – | Procedure: Photodynamic therapy (PDT)GBM patients recevied surgical combination photodynamic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- GBM patients recevied traditional treatment options (including surgery combined with radiotherapy and chemotherapy) or PDT treatment
Key inclusion criteria (1 listed)
- Pathologically confirmed primary focal GBM; Recurrent GBM(single or satellite lesions); Multiple (multiple germinal centers)GBM.
Key exclusion criteria (5 listed)
- Photosensitizer allergy.
- Non-gbm diagnosis: Patients with other types of brain tumors or diseases. 7 Do not agree to informed consent: patients who are unwilling to sign informed consent or do not agree to participate in the study.
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 |
|---|---|---|
| Photodynamic therapy (PDT)Also: Surgical combination photodynamic therapyGBM patients recevied surgical combination photodynamic therapy | Procedure or surgery | Treatment |
| GBM patients recevied traditional treatment optionsGBM patients recevied traditional treatment options (including surgery combined with radiotherapy and chemotherapy) | Procedure or surgery | Control |
Primary outcome
Number of Participants with Treatment of Surgical combination Photodyanmic therapy
Time frame: From June 2025 to June 2027
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 22 Apr 2025.
- Individual participant dataSharing planned: No
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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.
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 Glioblastoma Multiforme (GBM), run by Zhejiang Provincial People's Hospital 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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 22 Apr 2025. 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?
Contact Shaoshan Hu, Doctor (0571-85893451 ext. 0571-85893451, shaoshanhu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment of Surgical combination Photodyanmic therapy (time frame: From June 2025 to June 2027). 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 22 Apr 2025.