Brain Cancer Trial, Recruiting NCT05124912 Sponsor: Monteris Medical Condition: Brain Cancer
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Brain Cancer Trial, Recruiting

NCT05124912
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have brain metastases (cancer that has spread to the brain from another part of the body) confirmed by a special type of MRI scan using a contrast dye
  • People who have at least one brain lesion that has grown back or worsened after previously being treated with focused radiation (called SRS) and/or surgery
  • People whose target lesion has grown by at least 25% in size since previous treatment, based on standard measurement criteria
  • People whose target lesion is small enough in size to be treated using a single laser probe during the planned procedure (maximum width of 3 cm), though using two probes during surgery may also be acceptable (confirm with trial site)
  • People who are at least 3 months past their initial focused radiation (SRS) treatment of the target lesion
  • People whose target lesion can safely undergo both a tissue sample (biopsy) and laser heat treatment (LITT), as determined by the treating brain surgeon
  • People whose tissue sample can be assessed during surgery using a rapid laboratory technique called frozen pathology
  • People whose symptoms have been stable for at least 3 days before the procedure, while taking no more than a set low daily dose of steroid medication (equivalent to 4mg of dexamethasone)
  • People aged 18 or older
  • People with a general health and functioning score of 70 or above on a standard medical scale (KPS), meaning they are able to care for themselves and carry out normal activities (confirm with trial site)
  • People whose blood cell counts fall within acceptable levels, tested within 4 weeks before the biopsy — specifically, adequate white blood cell and platelet counts
  • People whose kidney function blood test result falls within an acceptable range, tested within 4 weeks before the biopsy
  • Female patients who have a negative pregnancy blood test before entering the study (this does not apply to those who have had both ovaries or the uterus removed, or who have gone through menopause)
  • People of reproductive potential who agree to use an effective form of contraception throughout the study
  • People who are able to attend follow-up visits as required by the study

Who may not be able to join:

  • People who have more than 3 brain lesions that are actively growing at the time of joining the study
  • People who have newly diagnosed brain metastases appearing at the same time as the target lesion being considered for treatment
  • People who have received the drug bevacizumab within 4 weeks before starting the study
  • People who are currently being actively treated for another cancer, with the exception of certain non-serious skin cancers or early-stage cervical cancer
  • People who have a serious active infection or other significant health conditions that would prevent them from completing the study's quality-of-life questionnaires and thinking/memory assessments
  • People who are unable to tolerate or have a medical reason not to take steroid medication (such as dexamethasone)
  • People who the treating brain surgeon and/or radiation specialist considers unable to safely receive focused radiation (SRS) therapy
  • People who have any condition that makes it unsafe for them to undergo a surgical procedure, as determined by their medical team
  • People who are unwilling or unable to give their informed consent to participate
  • People who are unable to meet the requirements of the study
  • People who have cancer that has spread widely across the lining of the brain and spinal cord (called leptomeningeal disease)
  • People whose cancer outside the brain is progressing rapidly

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Peter Fecci, MD, University of Colorado, Denver

Phone: 952-463-7747

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Monteris Medical
Registry
ClinicalTrials.gov
Start date
10 May 2022
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Progressive Disease Cohort; Radiation Necrosis Cohort

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov