Clinical trial for GBM
Official title WBSI Guided Personalized Delivery of TTFields
ClinicalTrials.gov ID: NCT05086497
What this study is testing
- What it's testing
- This study is testing whether a more precise MRI mapping helps Optune work better for glioblastoma patients.
- Who it's for
- You may be able to join if you have glioblastoma and are just starting Optune treatment.
- What's involved
- You will use the Optune device at home. Doctors will set it up with either the usual MRI map or a special whole‑brain spectroscopy map. You will have regular check‑ins.
- Time commitment
- The study lasts while you stay on Optune, with visits at the start and during follow‑up.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Adult population ≥ 22 years
- Histologically confirmed diagnosis of GBM or molecular GBM according to c-IMPACT NOW criteria
- Have undergone maximal safe surgical resection followed by either standard full course radiation of 6000 cGy in 6 weeks or a hypofractionated course...
- 3 Harboring any genotype profiles (MGMT promoter methylation or unmethylation and/or isocitrate dehydrogenase (IDH) mutant or IDH wild-type)
- Possessing adequate hematological, hepatic and renal functions
You likely can't join if
- Presence of infra-tentorial GBM
- Pregnancy
- Significant co-morbidities at baseline which would prevent maintenance TMZ treatment
- Active implanted medical device, a skull defect (such as missing bone with no replacement) or bullet fragments.
- Sensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS)...
- Presence of significant hemorrhage in and around the tumor bed that may potentially degrade the image quality.
See the full eligibility criteria
- Adult population ≥ 22 years
- Histologically confirmed diagnosis of GBM or molecular GBM according to c-IMPACT NOW criteria
- Have undergone maximal safe surgical resection followed by either standard full course radiation of 6000 cGy in 6 weeks or a hypofractionated course of 4000 cGy in 3 weeks
- 3 Harboring any genotype profiles (MGMT promoter methylation or unmethylation and/or isocitrate dehydrogenase (IDH) mutant or IDH wild-type)
- Possessing adequate hematological, hepatic and renal functions
- Willingness to receive TTFields
- Presence of infra-tentorial GBM
- Pregnancy
- Significant co-morbidities at baseline which would prevent maintenance TMZ treatment
- Active implanted medical device, a skull defect (such as missing bone with no replacement) or bullet fragments.
- Sensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes.
- Presence of significant hemorrhage in and around the tumor bed that may potentially degrade the image quality.
The study team makes the final eligibility decision.
Where it is enrolling
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.