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New treatment option for Spinal Metastasis
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
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with one or more spinal metastasis(es) affecting levels between C1 to S4 which have been previously treated with surgery and/or maximal...
- No more radiation options available for treatment to the spinal metastasis(es) that will undergo the TTF treatment
- Male or Female people 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...
- Patients must have a Karnofsky Performance Scale (KPS) (Appendix D) score of at least 70%.
You likely can't join if
- 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...
- Patients in the surgery group who have not fully recovered from the spinal surgery, where wound healing is compromised, requiring healing by second...
- History of allergic reactions or sensitivity to conductive hydrogels used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve...
- Implanted pacemaker, defibrillator, nerve stimulator or other active electronic medical devices in the area of surgery or application of the skin...
See the full eligibility criteria
Who can 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...
- No more radiation options available for treatment to the spinal metastasis(es) that will undergo the TTF treatment
- Male or Female people 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...
- 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.
- 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...
- 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.
What rules you out
- 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...
- 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.
- 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...
- Multiple noncontiguous progressive spine tumors separated by more than 25 cm.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.