Photodynamic Therapy for Glioblastoma Multiforme Based on Metaverse and Yellow Fluorescence

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06939400
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Zhejiang Provincial People's Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme (GBM)
Arms & Interventions

Arms

: Control

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

: Treatment

GBM patients recevied surgical combination photodynamic therapy

Interventions

Procedure: - Photodynamic therapy (PDT)

GBM patients recevied surgical combination photodynamic therapy

Procedure: - GBM patients recevied traditional treatment options

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

Contact a Trial Team

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International Sites

Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China

Status

Address

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014

Site Contact

Yi Yuan, Doctor

[email protected]

0571-85893451

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