Photodynamic Therapy for Glioblastoma Multiforme Based on... | NCT06939400

Studies
Photodynamic Therapy for Glioblastoma Multiforme Based on Metaverse and Yellow Fluorescence

NCT06939400

Sponsor

Zhejiang Provincial People's Hospital

Status

Not yet recruiting

Last Update Posted

Apr 22, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Glioblastoma Multiforme (GBM)

Interventions

Photodynamic therapy (PDT)
GBM patients recevied traditional treatment options

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

Jan 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2025Estimated

Primary Completion Date

Jun 30, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Feb 10, 2025

First Submission Date that Met QC Criteria

Apr 14, 2025

First Posted Date

Apr 22, 2025Actual

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

Apr 14, 2025

Last Update Posted Date

Apr 22, 2025Actual

Name	Class
The Second Affiliated Hospital of Harbin Medical University	OTHER

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

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.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control		GBM patients recevied traditional treatment options (including surgery combined with radiotherapy and chemotherapy)	Procedure: GBM patients recevied traditional treatment options
Treatment		GBM patients recevied surgical combination photodynamic therapy	Procedure: Photodynamic therapy (PDT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Photodynamic therapy (PDT)	Procedure	GBM patients recevied surgical combination photodynamic therapy	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with Treatment of Surgical combination Photodyanmic therapy		From June 2025 to June 2027

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathologically confirmed primary focal GBM; Recurrent GBM(single or satellite lesions); Multiple (multiple germinal centers)GBM.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

GBM patients recevied traditional treatment options (including surgery combined with radiotherapy and chemotherapy) or PDT treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shaoshan Hu, Doctor	Contact	0571-85893451	0571-85893451	shaoshanhu@163.com
Yi Yuan, Doctor	Contact	0571-85893451		zjsrmyykyb@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhejiang Provincial People's Hospital		Hangzhou	Zhejiang	310014	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005909	Glioblastoma

Ancestor Terms

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010778	Photochemotherapy

Ancestor Terms

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy
D010789	Phototherapy

Browse Leaves

Not provided

Browse Branches

Not provided