Spinal MetastasisPhase 1NCT06906900
A Phase I Study of the NovoTTF-200M and Novo TTF-200A Systems for the Treatment of Refractory Spinal Metastasis
A Phase 1 study testing TTF-200M and TTF-200A systems in people with Spinal Metastasis, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Metastasis
- What is being tested?
- TTF-200M and TTF-200A systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to 17 Feb 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with one or more spinal metastasis(es) affecting levels between C1 to S4 which have been previously treated with surgery and/or maximal doses radiation therapy to the spinal metastasis. For patients in the surgical group, patients must have completed maximal intralesional debulking of their tumor (within 90 days of enrollment).
- No more radiation options available for treatment to the spinal metastasis(es) that will undergo the TTF treatment
- Male or Female subjects aged ≥ 22 years.
- Women of child-bearing potential (women who are not postmenopausal for at least one year or are not surgically sterile) must agree prior to study entry to use adequate contraception (e.g., hormonal, barrier device, or abstinence) for the duration of study participation.
- Patients must have a Karnofsky Performance Scale (KPS) (Appendix D) score of at least 70%.
- Patients must have the ability to independently disconnect the arrays or turn off the system if they feel uncomfortably hot while using the device.
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- Patients (and/or legally authorized representative) should be able to fully understand the requirements of the trial, including the need to use the device for at least 18 hours per day, be willing to comply with all trial visits and assessments and be willing and able to sign an Institutional Review Board (IRB) approved written informed consent document (or provide assent where applicable).
- Patients with the following tumor histologies (numbers in parenthesis represent the frequencies/device patients with these histologies will be treated with):
- Non-small cell lung cancer (150KHZ, TTF-200M)
- Chordoma (150KHZ, TTF-200M)
- Breast adenocarcinoma (150HKZ, TTF-200M)
- Liver/gastrointestinal malignancy (150 KHZ, TTF-200M)
- Endocrine origin carcinoma (150KHZ, TTF-200M)
- Renal cell carcinoma (200KHZ, TTF-200A)
- Prostate adenocarcinoma (200KHZ, TTF-200A)
- Sarcoma (200KHZ, TTF-200A)
- For the non-surgical group only, expected survival of more than 8 months as confirmed by the primary oncologist.
- For the non-surgical group only, in case of multiple noncontiguous vertebral levels requiring treatment, all sites must be included under the largest length of the antero-posterior set of transducer arrays (25cm).
- Patients who have previously undergone surgery and already have spinal hardware implanted in the intended area of treatment may be enrolled in the surgical group, regardless of the timing of their original surgery.
Who cannot join
- Patients who meet any of the following exclusion criteria will not be eligible for the study:
- Psychiatric illness/social situations (homeless or living in a foreign country) that would limit compliance with study requirements.
- Physical or cognitive limitation that prevents the ability to independently disconnect the arrays or turn off the system if they feel uncomfortably hot while using the device. This includes patients that need a legally authorized representative for consent.
- Patients in the surgery group who have not fully recovered from the spinal surgery, where wound healing is compromised, requiring healing by second intention (i.e., the wound is left open and heals spontaneously).
- History of allergic reactions or sensitivity to conductive hydrogels used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes.
- Implanted pacemaker, defibrillator, nerve stimulator or other active electronic medical devices in the area of surgery or application of the skin transducers.
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- Women who are pregnant or lactating.
- Prior surgery to the spinal level(s) to be treated with TTF is not an exclusion criterion.
- Enrollment on another clinical trial with investigational drugs/devices is not an exclusion criterion and is kept at the discretion of the treating surgeon.
- Patients with leptomeningeal disease.
- Patients with severe pre-existing dermatological conditions (i.e., active herpes zoster, bullous pemphigoid reactions, Stevens-Johnson syndrome) that might interfere with interpretation of the device's skin toxicity.
- Patients receiving targeted therapy (i.e., EGFR inhibitors) who present with severe dermatological reactions at the site(s) to receive treatment with NovoTTF-200A or NovoTTF-200M. Prior treatment and complete resolution of a prior severe dermatological reaction are not exclusion criteria.
- Multiple noncontiguous progressive spine tumors separated by more than 25 cm.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Claudio Tatsui, MD, 713-563-8710, cetatsui@mdanderson.org
Claudio Tatsui, MD
About this study
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.
Read the detailed description
Primary Objective:
To evaluate the safety of applying TTFields at frequencies between 150 and 200KHz, using the TTF200M and TTF-200A systems (respectively), alone or in combination with available systemic therapies as adjuvant treatment in patients with radiation refractory spinal metastasis. Safety will be specifically assessed based on absence of wound dehiscence in the surgical group and severe cellulitis requiring drainage and intravenous antibiotics in both surgical and non-surgical cohorts.
Secondary Objective:
To assess local spine progression-free survivals at about every 3 months (+/- 1 month) in these patients until one of the following occurs: local disease progression, transition to hospice, loss of follow up, withdrawal from study or consent, whichever comes first.
Exploratory Objectives:
- To evaluate the safety of application of tumor treating fields at frequencies between 150kHZ and 200 KHZ using the TTF-200M and TTF-200A systems (respectively), alone or in combination with available systemic therapy as adjuvant treatment after surgery for spinal cord decompression in patients with refractory spinal metastasis
- To assess local spine progression-free survivals at about every 3 months (+/- 1 month) until their local disease progresses, they go to hospice, or are off study, whichever is earlier, in patients in 2.3(a).
- To evaluate the safety of application of tumor treating fields at frequencies between 150kHZ and 200 KHZ using the TTF-200M and TTF-200A systems (respectively), alone or in combination with available systemic therapy as adjuvant treatment for patients with radiation refractory spinal metastasis who are unable to undergo surgery due to high risk of complications.
- To assess local spine progression-free survivals at about every 3 months (+/- 1 month) until their local disease progresses, they go to hospice, or are off study, whichever is earlier, in patients in 2.3(c).
- To evaluate change in plasma ctDNA levels before initiation (baseline) to Cycle 1 and 3.
- Conditions
- Spinal Metastasis
- Being tested
- TTF-200M and TTF-200A systems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTF-200M and TTF-200A systemsDevice
Participants will receive treatment with NovoTTF-200M or NovoTTF-200A and treatment will continue as long as the doctor thinks it is in the participant's best interest.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with 150 KHZ (NovoTTF-200M) or 200KHZ (NovoTTF-200A) | Experimental | Not described Receives: Device: TTF-200M and TTF-200A systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start18 Aug 2025
- Primary completion17 Feb 2027 (estimated)
- Study completion17 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal MetastasisStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- NovoCure Ltd.
- Responsible party
- Sponsor
- Investigators
- Claudio Tatsui, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906900
- Sponsor's protocol ID
- 2024-1879
- Other IDs
- NCI-2025-02319
- Status last verified
- Oct 2026
- First submitted
- 26 Mar 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the NovoTTF-200M and Novo TTF-200A Systems for the Treatment of Refractory Spinal Metastasis
- ClinicalTrials.gov ID
- NCT06906900
- Acronym / sponsor ID
- 2024-1879
- Conditions
- Spinal Metastasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- NovoCure Ltd.
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 17 Feb 2027 (estimated)
- Study completion
- 17 Feb 2029 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective:
To evaluate the safety of applying TTFields at frequencies between 150 and 200KHz, using the TTF200M and TTF-200A systems (respectively), alone or in combination with available systemic therapies as adjuvant treatment in patients with radiation refractory spinal metastasis. Safety will be specifically assessed based on absence of wound dehiscence in the surgical group and severe cellulitis requiring drainage and intravenous antibiotics in both surgical and non-surgical cohorts.
Secondary Objective:
To assess local spine progression-free survivals at about every 3 months (+/- 1 month) in these patients until one of the following occurs: local disease progression, transition to hospice, loss of follow up, withdrawal from study or consent, whichever comes first.
Exploratory Objectives:
- To evaluate the safety of application of tumor treating fields at frequencies between 150kHZ and 200 KHZ using the TTF-200M and TTF-200A systems (respectively), alone or in combination with available systemic therapy as adjuvant treatment after surgery for spinal cord decompression in patients with refractory spinal metastasis
- To assess local spine progression-free survivals at about every 3 months (+/- 1 month) until their local disease progresses, they go to hospice, or are off study, whichever is earlier, in patients in 2.3(a).
- To evaluate the safety of application of tumor treating fields at frequencies between 150kHZ and 200 KHZ using the TTF-200M and TTF-200A systems (respectively), alone or in combination with available systemic therapy as adjuvant treatment for patients with radiation refractory spinal metastasis who are unable to undergo surgery due to high risk of complications.
- To assess local spine progression-free survivals at about every 3 months (+/- 1 month) until their local disease progresses, they go to hospice, or are off study, whichever is earlier, in patients in 2.3(c).
- To evaluate change in plasma ctDNA levels before initiation (baseline) to Cycle 1 and 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with 150 KHZ (NovoTTF-200M) or 200KHZ (NovoTTF-200A) | Experimental | Device: TTF-200M and TTF-200A systems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients with one or more spinal metastasis(es) affecting levels between C1 to S4 which have been previously treated with surgery and/or maximal doses radiation therapy to the spinal metastasis. For patients in the surgical group, patients must have completed maximal intralesional debulking of their tumor (within 90 days of enrollment).
- No more radiation options available for treatment to the spinal metastasis(es) that will undergo the TTF treatment
- Male or Female subjects aged ≥ 22 years.
- Women of child-bearing potential (women who are not postmenopausal for at least one year or are not surgically sterile) must agree prior to study entry to use adequate contraception (e.g., hormonal, barrier device, or abstinence) for the duration of study participation.
- Patients must have a Karnofsky Performance Scale (KPS) (Appendix D) score of at least 70%.
Key exclusion criteria (13 listed)
- Patients who meet any of the following exclusion criteria will not be eligible for the study:
- Psychiatric illness/social situations (homeless or living in a foreign country) that would limit compliance with study requirements.
- Physical or cognitive limitation that prevents the ability to independently disconnect the arrays or turn off the system if they feel uncomfortably hot while using the device. This includes patients that need a legally authorized representative for consent.
- Patients in the surgery group who have not fully recovered from the spinal surgery, where wound healing is compromised, requiring healing by second intention (i.e., the wound is left open and heals spontaneously).
- History of allergic reactions or sensitivity to conductive hydrogels used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTF-200M and TTF-200A systemsParticipants will receive treatment with NovoTTF-200M or NovoTTF-200A and treatment will continue as long as the doctor thinks it is in the participant's best interest. | Device | Treatment with 150 KHZ (NovoTTF-200M) or 200KHZ (NovoTTF-200A) |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudio Tatsui, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TTF-200M and TTF-200A systems in people with Spinal Metastasis, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudio Tatsui, MD ((713) 563-8710, cetatsui@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.