Houston, TXNCT03028246Now EnrollingIRB Ready

Benign Centrally-Located Intracranial Tumors Clinical Trial in Houston, TX

Access cutting-edge benign centrally-located intracranial tumors treatment through this clinical trial at a research site in Houston. Study-provided care at no cost to qualified participants.

Sponsored by InSightec

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Expert Care in Houston

Access benign centrally-located intracranial tumors specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related benign centrally-located intracranial tumors treatment provided free

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Check if you qualify for this benign centrally-located intracranial tumors clinical trial in Houston, TX

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Why Participate?

  • No-Cost Study Care

  • Local to Houston

    Convenient for TX residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Houston site if eligible
  4. 4Begin participation

About This Benign Centrally-Located Intracranial Tumors Study in Houston

The goal of this prospective, non-randomized, single-arm, feasibility study is to develop data to evaluate the safety and feasibility of ExAblate 4000 treatment of benign intracranial tumors which require clinical intervention in pediatric and young adult subjects. Indication of Use: Ablation of benign intracranial tumors in children and young adults which are ExAblate accessible.

Sponsor: InSightec

Who Can Participate

Inclusion Criteria

Subjects with benign (WHO grade I) centrally located intracranial tumors which require clinical intervention and are known to carry minimal hemorrhage risk
Minimum head circumference will be 49cm
Skull Density Ratio (SDR) should be ≥0.35
Subjects should be on a stable dose of all condition-related medications for 30 days prior to study entry as determine by medical records
Subjects and/or parent(s)/legal representative can provide accurate seizure diary log for the 30 days prior to FUS treatment and for the duration of the study

Exclusion Criteria

Subjects with unstable cardiac status that would increase anesthetic risk including
Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV
Subjects who are taking human growth hormone (hGH), also known as somatotropin
Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including vagus nerve stimulator, responsive neurostimulator, cardiac pacemakers, non-metallic shunts, size limitations, etc.
Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) or sedative medications
Severely impaired renal function (estimated glomerular filtration rate \<70% of normal GFR for age) or receiving dialysis
Any history of clinically significant abnormal bleeding and/or coagulopathy
Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin, NSAIDs) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure; or, unable or unwilling to stop anticoagulant for the purpose of focused ultrasound procedure
Use of valproate derivatives for seizure control within the preceding 2 weeks
Known or suspected acute, active, or uncontrolled infection
History of postnatal stroke or intracranial hemorrhage within 6 months
Clinical suspicion of increased intracranial pressure (as evidenced by symptoms of obstruction: headache, nausea, vomiting, lethargy, and papilledema)
Have participated in another interventional trial in the last 30 days
History of immunocompromise, including subject who is HIV positive with incomplete viral suppression
Known life-threatening systemic disease
Subjects with suicidal ideation or previous suicide attempt within the past year
Subjects with malignant brain tumors, or the presence of any ambiguous clinical features that could imply a malignant potential to the tumor, or for which a biopsy is necessary
Subjects for whom histopathology is important for ongoing management
Female subjects who are pregnant, breast feeding or planning to become pregnant during the study or are unwilling to practice birth control during participation in the study, if of child-bearing age

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT03028246) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Benign Centrally-Located Intracranial Tumors Treatment Options in Houston, TX

If you're searching for benign centrally-located intracranial tumors treatment options in Houston, TX, this clinical trial (NCT03028246) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced benign centrally-located intracranial tumors specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all benign centrally-located intracranial tumors clinical trials near you to find additional studies recruiting in your area.

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