NCT02441322Completed
Evaluating Therapeutic Response to Novo-TTF
High Resolution MRI and MRS to Evaluate Therapeutic Response to Novo-TTF in Newly and Recurrent Glioblastomas
Source: ClinicalTrials.gov · Last updated 19 Jul 2024
Brief summary (registry, in English)
This study is to assess the utility of high resolution 3D echo planar magnetic resonance spectroscopy (3D EPSI) in monitoring Novo-TTF response in glioblastoma multiforme (GBM) patients.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 11 Feb 2015
- Start date
- Dec 2014
- Primary completion date
- Jun 2023
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Diseases
- Glioblastoma
- NCT number
- NCT02441322
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From Dec 2014 to the primary completion date, Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias
- History of hypersensitivity reaction to Temozolomide or a history of hypersensitivity to DTIC.
Lab values
- Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment:
- Thrombocytopenia (platelet count less than 100 x 1000 per microlitre)
- Neutropenia (absolute neutrophil count less than 1.5 x 1000 per microlitre)
- CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
- Significant liver function impairment AST or ALT 3 times the upper limit of normal
- Total bilirubin upper limit of normal
- Significant renal impairment (serum creatinine greater than 1.7 mg/dL)
Other
- Actively participating in another clinical treatment trial
- Pregnant
- Infra-tentorial tumor
- Evidence of increased intracranial pressure (midline shift 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
Who the study is looking for
- Newly diagnosed or recurrent GBMs
- Received maximal debulking surgery and radiotherapy (protons or photons) concomitant with Temozolomide (40-75Gy)
- Patients may enroll in the study if received Gliadel wafers before entering the trial.
- Minimal dose for concomitant radiotherapy is 40 Gy
- Karnofsky scale of 60 or greater
- Life expectancy at least 3 months
- Must sign written informed consent
- Treatment start date at least 4 weeks out from surgery or as soon as skin healing/radiation reaction allows
- Measurable enhancing neoplasm on post contrast T1 weighted images and/or non enhancing FLAIR signal abnormality
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.