home/imdoinit.org

Tumor Electric Fields Treatment System for Glioblastoma

Study Purpose

This early phase I trial will investigate the safety and feasibility of applying the Tumor Electric Fields Treatment System to subjects with recurrent glioblastoma.

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.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients with pathological diagnosis of glioblastoma at first surgery (WHO Grade IV, supratentorial location); - Age between 18 and 65 years, male or female; - Previously completed radiotherapy and at least two cycles of chemotherapy; - With imaging or pathological evidence of tumor recurrence; - Karnofsky performance score (KPS) score ≥ 70 before intervention; - With a life expectancy more than 3 months; - Adopted effective contraceptive measures at child-bearing age; - Provided written informed consent.

Exclusion Criteria:

- Patients unwilling to use the equipment ≥ 18h per day; - With poor compliance or live too far from the research center, who cannot keep regular follow-up or adjust the electrode position of the treatment equipment, and who refuse to receive follow-up to terminal survival; - With poor healing of scalp wound, poor scalp condition, large skull defect or other cases where electrodes are not suitable for wearing; - Within 3 months from radiotherapy; - Within 4 weeks from the last cycle of chemotherapy; - Within 4 weeks from surgery for recurrence; - Participated in other clinical trials.

- Pregnant; - Epilepsy symptoms not effectively controlled; - Blood and biochemical indicators in the following range: A.

Liver function impairment: AST or ALT > 3 times the upper limit of normal; B. Total bilirubin> upper limit of normal value; C. Renal impairment: serum creatinine>1.7mg /dL (>150 mol/L); D. Coagulopathy: PT or APTT >1.5 times normal; E. Platelets counts < 100x10^9/L; F. Absolute neutrophils count < 1x10^9/L; G. Hemoglobin < 100g/L;

- With severe infectious diseases, such as acute severe infection and HIV positive; - Other conditions, such as an implanted cardiac pacemaker or deep brain stimulator, severe intracranial edema, increased intracranial pressure resulting in midline shift>5mm, clinically significant papilledema, or reduced level of consciousness, allergy to conductive coupling agent, gel, and other serious life-threatening diseases.

- Other circumstances considered inappropriate to participate in the research by the investigator.

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.	NCT04417933
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.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Xiangya Hospital of Central South University
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	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Additional Details

Subjects who have previously completed radiotherapy and at least two cycles of chemotherapy with imaging or pathological evidence of tumor recurrence will receive Tumor Electric Fields Treatment System. The main objective is to evaluate the safety of applying the Tumor Electric Fields Treatment System to subjects with recurrent GBM.

Arms & Interventions

Arms

Experimental: Tumor Electric Fields Treatment System

Patients have a histologically confirmed diagnosis of supratentorial glioblastoma that is recurrent. All patients will receive Tumor Electric Fields Treatment System.

Interventions

Device: - Tumor Electric Fields Treatment System

Patients wear two pairs of electrodes on the head for 19-22 hours a day. Each patient is required to wear the device as long as possible and not less than 6 months. The treatment has a two-day break for every four weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Changsha, Hunan, China

Status

Recruiting

Address

Xiangya Hospital Central South University

Changsha, Hunan, 410000

Site Contact

Zhixiong Liu, M.D.

zhixiongliu@csu.edu.cn

+8613607318785

Clinical Trial Finder