Durham, NCNCT05124912Now EnrollingIRB Ready

Brain Metastases Clinical Trial in Durham, NC

Access cutting-edge brain metastases treatment through this clinical trial at a research site in Durham. Study-provided care at no cost to qualified participants.

Sponsored by Monteris Medical

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Expert Care in Durham

Access brain metastases specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related brain metastases treatment provided free

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Check if you qualify for this brain metastases clinical trial in Durham, NC

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Durham

    Convenient for NC 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 Durham site if eligible
  4. 4Begin participation

About This Brain Metastases Study in Durham

Randomized, post-market multi-center study investigating the efficacy of two sets of treatment algorithms in brain metastases (BM) patients at the time of first intervention for radiographic progression after stereotactic radiosurgery (SRS), with or without surgery.

Sponsor: Monteris Medical

Who Can Participate

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Patients with radiographically proven (by gadolinium-enhanced \[Gd-\] MRI) parenchymal brain metastases from histologically confirmed non-central nervous system (CNS) cancer.
Patients with a "targetable", bidimensionally-measurable, intracranial lesion that is radiographically recurrent after previous treatment with SRS +/- surgery (craniotomy or LITT). To classify a lesion as radiographically progressive, the lesion must demonstrate a ≥ 25% increase in size following treatment based on the Neuro-Oncology Criteria of Tumor Response for CNS Tumors. To be "targetable" for this study, the lesion should be coverable through a planned single LITT trajectory and thus have a maximum perpendicular diameter (perpendicular to the laser trajectory) of 3 cm. An intra-operative decision to utilize two trajectories is acceptable and patient may remain on study.
Patient must be at least 3 months post initial SRS treatment of the target lesion
Target lesion must be amenable to undergo surgical biopsy and LITT treatment as determined by the treating neurosurgeon.
Frozen pathology diagnosis must be attainable.
Patient must be symptomatically stable for a minimum of 3 days prior to the procedure date on a on a max total daily steroid dose equivalent to 4mg of Dexamethasone.
≥18 years of age
Patient is able and willing to complete study requirements
Patients with adequate hematologic parameters (all tests to be performed within \<4 weeks of biopsy):
ANC ≥ 1.5 X 109/L
Platelet count ≥ 100 x 109/L
Blood chemistry laboratory value for serum creatinine \< 1.5 x ULN (test to be performed within \<4 weeks of biopsy)
Female patients must have a negative serum pregnancy test at screening. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal)
All patients of reproductive potential must agree to use an effective method of contraception during the study
Patients must be accessible for follow-up

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:
Patients with greater than 3 progressing lesions at time of enrollment. To classify as a radiographically progressive, lesion must demonstrate a ≥ 25% increase in size following treatment based on the RANO criteria. Of note, there is no exclusion for total number of metastases. However, only one lesion can be selected to be the targeted lesion and this lesion alone may be ablated during the study procedure.
Patients with concomitant newly diagnosed intracranial metastases (concurrent with the targetable radiographically progressive lesion), as these will require prioritized and different treatment approaches.
Prior bevacizumab use within 4 weeks of study initiation
Patients with additional concurrent malignancies requiring active treatment, except non-melanoma skin cancer, or in-situ cancer of the cervix
Patients with a serious active infection or other serious underlying medical conditions that would impair the ability of the patient to complete the protocol related QOL questionnaires and cognition assessments
Inability to tolerate or contraindication to steroid therapy (i.e., dexamethasone)
Deemed ineligible or unable to tolerate SRS therapy by treating neurosurgeon and/or radiation oncologist
Patients with any condition that would prohibit them from undergoing a surgical procedure, at the discretion of the treating physician team
Patients unwilling or unable to give consent for participation
Patients unable to comply with study requirements
Patients with diffuse leptomeningeal disease
Patients with rapidly progressing extracranial disease

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 Durham?

Yes, this clinical trial (NCT05124912) has an active research site in Durham, NC 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.

Brain Metastases Treatment Options in Durham, NC

If you're searching for brain metastases treatment options in Durham, NC, this clinical trial (NCT05124912) 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 Durham research site is actively enrolling participants for this clinical trial. You'll receive care from experienced brain metastases 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 brain metastases clinical trials near you to find additional studies recruiting in your area.

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