ROADS CLINICAL STUDY for PATIENTS WITH NEWLY DIAGNOSED METASTATIC BRAIN TUMORS | REFER A PATIENT

Study FAQs

SRT is a precise form of external beam radiation therapy (EBRT) that is typically completed on an outpatient basis in a series of 1 to 5 treatments.2
GammaTile is a targeted form of internal radiation therapy, also known as brachytherapy. Placed at the time of brain tumor–removal surgery, GammaTile immediately begins delivering radiation to the area where the tumor was removed.3,4

Study participants will be randomly divided into 2 treatment groups: brain tumor removal surgery + SRT and brain tumor removal surgery + GammaTile. Following brain tumor removal surgery, study participants will receive either GammaTile or SRT to the area where the tumor was removed.

Note that study participants in both groups may have additional brain tumors that may not be suitable for surgical removal. These remaining brain tumors will be treated with SRT, so you may also receive SRT if you’re in the surgery + GammaTile group.

In many cases, yes. Previous or ongoing treatment with chemotherapy, targeted therapeutics, or immunotherapy is permitted though it must comply with the specific study guidelines.
Participating in the study may not delay your tumor removal surgery, but you must qualify and enroll at least a week in advance of your surgery. That’s why it’s important that you contact your participating hospital as soon as possible to enroll in this clinical study.
If your surgery has been scheduled at a ROADS Study participating hospital and it’s at least a week or more away, you may still be able to participate in the study. Please contact the ROADS Clinical Team ASAP to schedule an appointment.

If your surgery has been scheduled at a nonparticipating hospital, you may be eligible for a second opinion at a ROADS Study participating hospital prior to your surgery.
Possibly, depending upon the investigational drug, the study, and its exclusions. Please discuss this with your ROADS Clinical Study team and your medical care team.
Yes. The treatments offered in the ROADS Clinical Study are commonly used for patients with metastatic brain tumors. In addition, a physician and the medical research team will closely oversee your care.

Health insurance usually covers the cost of these FDA-cleared treatments. The ROADS Clinical Study team will confirm your insurance coverage prior to your enrollment.

Study participants at some, but not all, participating hospitals may be paid up to $50 per study visit.

Ask your ROADS Clinical Study team for details.

Prior to your brain tumor–removal surgery, you’ll need to complete these study enrollment steps:

  1. Schedule an appointment with the ROADS Clinical Study team to confirm that you qualify for the study and take the screening tests.

                  a. Sign the informed consent study form.
                  b. Take a pregnancy test if you are a female of childbearing age.
                  c. Answer a questionnaire about your quality of life.
                  d. Take brain function assessments.
       2. Receive your treatment group assignment (surgery +SRT or surgery + GammaTile).

Next, the ROADS Clinical Team will schedule your surgery, and you’ll be on track to receive your treatment(s). Follow-up visits will be scheduled at 1, 3, 6, 9, 12, 16, and 24 months, which will coincide with your follow-up visits to your physician.

References:

  1. Mayo Clinic Website. Brain Metastases. https://www.mayoclinic.org/diseases-conditions/brain-metastases/symptoms-causes/syc-20350136. Accessed November 8, 2021.
  2. RT Answers Web site. https://rtanswers.org/How-does-radiation-therapy-work/Stereotactic-Radiation-Therapy. Accessed February 6, 2022.
  3. Brachman D, Youssef E, Dardis C, Smith K, Pinnaduwage D, Nakaji P. Surgically targeted radiation therapy: Safety profile of collagen tile brachytherapy in 79 recurrent, previously irradiated intracranial neoplasms on a prospective clinical trial. Brachytherapy. 2019;18(3):S35-S36.
  4. GammaTile Therapy Instructions for Use. Tempe, AZ. GT Medical Technologies; 2020.

The ROADS Study is sponsored by GT Medical Technologies, Inc., the makers of GammaTile. Please discuss the risks and benefits of participating in this clinical study with your care team.

Indications

GammaTile is indicated to deliver radiation therapy in patients with newly diagnosed malignant and recurrent brain tumors. Possible complications can occur with any neurosurgical procedure and include cerebrospinal fluid leaks, infection, delayed hemorrhage, and adhesion formation. For full product and safety information, speak to your physician and refer to the instructions for use.

ROADS CLINICAL STUDY for PATIENTS WITH NEWLY DIAGNOSED METASTATIC BRAIN TUMORS

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