NovoTTF-200M and NovoTTF-200A for Refractory Spinal Metastasis
This study is testing the safety of two medical devices, the NovoTTF-200M and NovoTTF-200A Systems, for people with spinal metastasis (cancer that has spread to the spine). These systems use Tumor Treating Fields (TTFields) to target cancer cells. You might be able to join if you are 18 or older and have spinal metastasis that has already been treated with surgery and/or radiation, but the cancer did not respond. The study aims to see how safe these devices are, especially looking for issues like wound healing problems after surgery or severe skin infections. Treatment will continue as long as your doctor believes it is beneficial for you. This study plans to enroll 30 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.
- What's involved
- Participants will receive treatment with NovoTTF-200M or NovoTTF-200A. Treatment will continue as long as the doctor thinks it is in the participant's best interest.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and adverse events will be measured through study completion, which is an average of 1 year. Local spine progression-free survival will be assessed about every 3 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase I Study of the NovoTTF-200M and Novo TTF-200A Systems for the Treatment of Refractory Spinal Metastasis
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Claudio Tatsui, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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What this trial measures
- Safety and Adverse Events (AEs)Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0