A Explorative Study to Evaluate the Clinical Feasibility of AVATAMED

Doo-Sik Kong

Status: Unknown

Conditions: Glioblastoma

Treatments: Device: AVATAMED

Study type: Observational

Funder types: Other

Identifiers

NCT04313842

2018-12-071

Details and patient eligibility

About

This is an exploratory study to evaluate the clinical feasibility of medical deivce 'AVATAMED' for predicting the clinical response to TMZ (temozolomide) in glioblasotma patients.

Full description

Glioblastoma patients who would take TMZ treatment will be screened for in vitro drug screening experiment. Patients whose tumor specimen pass the drug screening process will be finally enrolled.

Actual clinical response to TMZ treatment will be compared to drug screening results derived from AVATAMED, a medical software device to predict the drug response based on in vitro assay using patient-derived tumor cells.

Enrollment: 40 estimated patients

Sex: All

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. written informed consent
2. histologically confirmed glioblastoma patients who will take TMZ treatment
3. KPS >70
4. adequte end-organ function
5. prior major surgery > 4 weeks (prior minor surgery > 1weeks)
6. prior standard concurrent chemo-radiation therapy > 4 weeks
7. prior radiation therapy (including stereotactic radiosurgery) > 12 weeks

Exclusion criteria

1. contraindication to TMZ
2. prior anti-cancer therapy except standard of care (*standard of care includes surgery, Stupp regimen, and radiotherapy)
3. uncontrolled systemic medical illness
4. pregnancy