Recruiting PHASE2 Brain Metastases

New treatment option for Brain Metastases

Official title Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

ClinicalTrials.gov ID: NCT05692635

What this study is testing

What is Gadolinium?

Gadolinium is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for brain metastases.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The purpose of this research is to see if monitoring the brain using magnetic resonance imaging (MRI) after radiation therapy will allow investigators to find cancer that has spread to the brain (brain metastases) before it causes symptoms.
  • Phase 2: a mid-size study of how well it works

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

  • Age ≥ 18 years of age.
  • Patients with non-squamous locally advanced lung cancer defined by American Joint Committee on Cancer (AJCC) version 8 stage IIIA, IIIB, or IIIC...
  • Histology described as adeno-squamous or not otherwise specified favoring squamous are eligible.
  • Patients may be enrolled before or after the start of radiation therapy but must be enrolled and have their first surveillance MRI brain at 120 +/-...
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3.

You likely can't join if

  • Known brain metastases on staging MRI.
  • Questionable findings that may represent a differential of vasculature abnormalities/stroke/ and or metastatic disease with recommended short...
  • Patients who are pregnant or breastfeeding.
  • Premenopausal persons of childbearing potential must have a negative pregnancy test within 14 days of enrollment. If women are not of childbearing...
See the full eligibility criteria
Who can join
  • Age ≥ 18 years of age.
  • Patients with non-squamous locally advanced lung cancer defined by American Joint Committee on Cancer (AJCC) version 8 stage IIIA, IIIB, or IIIC disease.
  • Histology described as adeno-squamous or not otherwise specified favoring squamous are eligible.
  • Patients may be enrolled before or after the start of radiation therapy but must be enrolled and have their first surveillance MRI brain at 120 +/- 10 days of their first treatment of radiation therapy for their locally...
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3.
  • Epidermal growth factor receptor (EGFR) \> 30 mL/min/1.73m2.
  • Patients must be eligible for a brain MRI per the Wake Forest MRI safety screening checklist questionnaire. This will be completed by a MRI imaging technician, enrolling physician, CPDM staff member, a magnetic...
What rules you out
  • Known brain metastases on staging MRI.
  • Questionable findings that may represent a differential of vasculature abnormalities/stroke/ and or metastatic disease with recommended short interval follow-up are not an exclusion factor for study participation. The...
  • Patients who are pregnant or breastfeeding.
  • Premenopausal persons of childbearing potential must have a negative pregnancy test within 14 days of enrollment. If women are not of childbearing potential as defined by women who are menopausal female or has had a...

The study team makes the final eligibility decision.

Where it's taking place

  • Winston-Salem, North Carolina, 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 Winston-Salem, North Carolina, 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.