NCT06939400

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Jun 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress36%
Jun 2025Dec 2027

First Submitted

Initial submission to the registry

February 10, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 22, 2025

Status Verified

January 1, 2025

Enrollment Period

2.1 years

First QC Date

February 10, 2025

Last Update Submit

April 14, 2025

Conditions

Keywords

Glioblastoma Multiformephotodynamic therapymetaverseyellow fluorescence

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Treatment of Surgical combination Photodyanmic therapy

    From June 2025 to June 2027

Study Arms (2)

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

GBM patients recevied surgical combination photodynamic therapy

Also known as: Surgical combination photodynamic therapy
Treatment

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

Control

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Central Study Contacts

Shaoshan Hu, Doctor

CONTACT

Yi Yuan, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of neurosurgery department

Study Record Dates

First Submitted

February 10, 2025

First Posted

April 22, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations