24 februari 2018: zie ook dit artikel voor laatste update van deze behandeling:
3 mei 2017: lees ook dit artikel:
26 april 2011: Bron FDA
De FDA heeft nu ook het NOVO TTF-100A systeem officieel goedgekeurd om te gebruiken als behandelings apparaat voor hersentumoren. Het voordeel van dit apparaatje is dat u het thuis kunt gebruiken. Zie in gerelateerde artikelen enkele studies met dit apparaatje waarin ook adres om u op te geven voor deelname aan studies. Hier het officiele persbericht van de FDA:
FDA approves new medical device for form of brain cancer, glioblastoma multiforme
FDA NEWS RELEASE
For Immediate Release: April 15, 2011
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves new medical device for form of brain cancer
The U.S. Food and Drug Administration recently approved the NovoTTF-100A System, a new device to treat adults with glioblastoma multiforme (GBM) that recurs or progresses after receiving chemotherapy and radiation therapy.
Brain tumors are the growth of abnormal cells in the brain tissue. According to the National Cancer Institute, each year about 19,000 people in the United States are diagnosed with primary brain cancers. In 2010, there were 13,140 deaths from brain and other nervous system cancers in the United States.
GBM is the most common primary brain cancer. The brain tumor is highly resistant to standard treatments such as surgery, radiation and chemotherapy.
When using the NovoTTF-100A System, a health care professional places electrodes on the surface of the patient’s scalp to deliver low-intensity, changing electrical fields called “tumor treatment fields” (TTFs) to the tumor site. The unique shape and electrical characteristics of dividing tumor cells make them susceptible to damage when exposed to TTF, which could stop tumor growth.
The device is portable and can be powered with batteries or plugged into an electrical outlet. Patients can use the device at home, allowing them to continue their normal daily activities.
“Recurrent glioblastoma multiforme is a devastating form of brain cancer that often eludes standard treatments,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The agency’s approval of the NovoTTF-100A System shows FDA’s commitment to innovative new devices that provide patients with other treatment options.”
The FDA based its approval of the NovoTTF-100A System on results from a single international clinical study in 237 patients with recurrent GBM or with GBM that hadn’t responded to traditional therapy. Patients in the study were randomly assigned to receive either the NovoTTF-100A System or chemotherapy treatment.
The study showed comparable overall survival rates between patients treated with the NovoTTF-100A System and those who underwent chemotherapy.
Patients treated with the NovoTTF-100A System experienced a slightly higher incidence of neurological side effects including convulsions and headaches compared to patients receiving chemotherapy. However, they did not experience the significant side effects associated with chemotherapy, including nausea, anemia, fatigue and serious infections.
A survey of patients in the study suggested an improved quality of life in the NovoTTF-100A recurrent GBM patients compared to patients receiving chemotherapy.
Patients should not use the NovoTTF-100A System if they have an implanted medical device or a skull defect, or have a known sensitivity to conductive hydrogels, such as those used with electrocardiograms. The NovoTTF-100A System is not intended to be used in combination with other cancer treatment. The device should only be used after other treatments have failed.
The NovoTTF-100A System is made by Novocure of Portsmouth, N.H.
Gerelateerde artikelen
- NovoTTF™-100A (TTF = vorm van electro hyperthermie) geeft veel langere mediane overleving, 5 maanden, bij nieuwe diagnose hersentumoren glioblastoma in vergelijking met temodal - temozolomide alleen
- NOVO TFF-100A: Fase III studie met electroden aanpak (NovoTTF-100A) van recidief van hersentumoren (Recidief van Glioblastoma Multiforme) geeft betere resultaten dan chemo.
- NovoTTF therapie - electrische pulsen - geeft vergelijkbare overlevingstijd dan met chemo bij patiënten met een recidief van een hersentumor glioblastoom multiforme. Kwaliteit van leven blijkt met de NOVO TTF veel beter.
- Behandeling met electrische pulsen geeft verdubbeling van overlevingstijd voor kankerpatienten met een inoperabel recidief van een hersentumor glioblastoma multiforma (GBM).
- FDA geeft officieel toestemming voor gebruik van het NovoTTF-100A systeem, electrische velden, bij hersentumoren glioblastomen multiforme.
- NOVO TFF-100A: een overzicht van artikelen
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