Recruiting PHASE2 Brain Metastases, Adult

New treatment option for Brain Metastases, Adult

Official title Stereotactic Radiation for Growing/Changing Brain Metastases With Same-Day Radiation Planning and Treatment With Margin Reduction

ClinicalTrials.gov ID: NCT07132190

What this study is testing

What it's testing
The goal of this study is to evaluate the feasibility and effectiveness of same-day radiation planning and treatment. The study will shorten the time interval between radiation planning (radiation mapping) and radiation treatment.
  • Phase 2: a mid-size study of how well it works
  • Which group you join is decided by chance.

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

  • Participants must have a biopsy proven solid malignancy with at least one intact, residual or recurrent, intracranial lesion radiographically...
  • Growth of 1.0mm per week or more, on average, based on the two most recent brain MRIs preceding study enrollment
  • Abutment, to within 1.0cm, of a region of intracranial edema
  • Proximity (within 5.0cm) to a surgical cavity created within 30 days of enrollment
  • Proximity (within 5.0cm) to another source of physical displacement

You likely can't join if

  • Participants who cannot tolerate a brain MRI
  • Patients who cannot receive gadolinium
  • Participants with end stage renal disease
  • Participants with widespread, definitive leptomeningeal disease
  • Pregnant women are excluded from this study because of the potential deleterious effects of gadolinium on the developing fetus. Because there is an...
See the full eligibility criteria
Who can join
  • Participants must have a biopsy proven solid malignancy with at least one intact, residual or recurrent, intracranial lesion radiographically consistent with or pathologically proven to be a brain metastasis meeting one...
  • Growth of 1.0mm per week or more, on average, based on the two most recent brain MRIs preceding study enrollment
  • Abutment, to within 1.0cm, of a region of intracranial edema
  • Proximity (within 5.0cm) to a surgical cavity created within 30 days of enrollment
  • Proximity (within 5.0cm) to another source of physical displacement
  • Age of at least 18 years
  • Karnofsky performance status of at least 60
  • Estimated survival of at least 3-6 months in the opinion of the enrolling clinician and/or study PI
  • Ability to understand and the willingness to sign a written informed consent document by either ink on paper or a DF/HCC approved eConsent medium
What rules you out
  • Participants who cannot tolerate a brain MRI
  • Patients who cannot receive gadolinium
  • Participants with end stage renal disease
  • Participants with widespread, definitive leptomeningeal disease
  • Pregnant women are excluded from this study because of the potential deleterious effects of gadolinium on the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants, women...

The study team makes the final eligibility decision.

Where it's taking place

  • Boston, Massachusetts, 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 Boston, Massachusetts, 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.