Actively Recruiting
A Phase I Study of the NovoTTF-200M and Novo TTF-200A Systems for the Treatment of Refractory Spinal Metastasis
Led by M.D. Anderson Cancer Center · Updated on 2026-04-20
30
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
NovoCure Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical research study is to learn about the safety of the NovoTTF-200M and Novo TTF-200A Systems, when used either alone or in combination with standard therapy, in patients with tumors that did not respond to treatment.
CONDITIONS
Official Title
A Phase I Study of the NovoTTF-200M and Novo TTF-200A Systems for the Treatment of Refractory Spinal Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with one or more spinal metastases between C1 and S4 previously treated with surgery and/or maximal radiation
- For surgical patients, completed maximal tumor debulking within 90 days before enrollment
- No further radiation options available for the spinal metastases to be treated
- Male or female aged 22 years or older
- Women of child-bearing potential must agree to use effective contraception during the study
- Karnofsky Performance Scale score of at least 70%
- Ability to independently disconnect device arrays or turn off system if uncomfortable heat occurs
- Ability and willingness to understand trial requirements, use device at least 18 hours daily, comply with visits, and provide informed consent
- Specific tumor types including non-small cell lung cancer, chordoma, breast adenocarcinoma, liver/gastrointestinal, endocrine carcinoma, renal cell carcinoma, prostate adenocarcinoma, and sarcoma
- For non-surgical patients, expected survival over 8 months
- For non-surgical patients with multiple vertebral levels, all sites must fit within the transducer array area
- Patients with prior spinal surgery and implanted hardware may be in the surgical group regardless of surgery timing
You will not qualify if you...
- Psychiatric or social conditions limiting study compliance, such as homelessness or living abroad
- Physical or cognitive impairments preventing independent device disconnection or shutdown
- Surgical patients with wounds not fully healed or requiring healing by second intention
- Allergies or sensitivities to conductive hydrogels used on device electrodes
- Presence of implanted active electronic medical devices in treatment area (e.g., pacemakers)
- Pregnancy or lactation
- Leptomeningeal disease
- Severe pre-existing skin conditions affecting device skin toxicity evaluation
- Severe dermatological reactions related to targeted therapies at treatment sites
- Multiple noncontiguous progressive spinal tumors separated by more than 25 cm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Claudio Tatsui, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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