RightFit
RecruitingPhase 4

Brain [18F]-FES PET/CT in Patients With Estrogen-Receptor Positive Breast Cancer

Brain [18F]-FES PET/CT in the Diagnosis, Treatment Planning and Response Assessment of Brain Metastases in Patients With Estrogen-Receptor Positive Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, Biopsies, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients will undergo MRI of the brain and FDG PET/CT brain as part of standard of care for radiation treatment planning."
  • "Patients will be followed prospectively with clinical and MRI assessments per standard-of-care for a total of 12 months."
  • "Study Population: Patients with ER-positive breast cancer with biopsy proven or suspected new or recurrent brain metastases (based on standard of care MRI) planned for radiation treatment of brain lesions."
  • "Overall Design All subjects will undergo a MRI brain and FDG PET/CT brain scan as part of clinical standard- of-care for radiation treatment planning."
  • "The 18F-FES PET/CT scan will be completed within approximately 2 days to 4 weeks of the 18F-FDG PET/CT, and 2 days to 4 weeks of the MRI brain, respectively."
  • "While MRI and PET can be performed on the same day if needed, the 18F-FDG PET/CT and 18F-FES PET/CT have to be separated by at least 1 day, to allow for 10 half-lives of 18F (10 times 108 minutes = 18 hours) to pass in order to avoid signal overlap on the second PET/CT scan."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study aims to improve how an FES PET/CT brain scan is done. It is for adults with estrogen receptor-positive (ER+) breast cancer, which uses estrogen to grow, that has or may have spread to the brain. Patients will have an extra brain scan before planned radiation treatment and be followed for 12 months.

The goal of this interventional study is to optimize the protocol of FES PET/CT in Estrogen Receptor positive Breast cancer patients with Brain metastases. Patients will undergo MRI of the brain and FDG PET/CT brain as part of standard of care for radiation treatment planning. An additional 18F-FES PET/CT brain scan will be completed before this standard of care radiation treatment. Patients will be followed prospectively with clinical and MRI assessments per standard-of-care for a total of 12 months. Study Population: Patients with ER-positive breast cancer with biopsy proven or suspected new or recurrent brain metastases (based on standard of care MRI) planned for radiation treatment of brain lesions.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have ER+ breast cancer confirmed by a biopsy (a tissue test).
  • Have new or returning cancer in the brain, confirmed by a biopsy or suspected on an MRI scan.
  • Be able to understand and agree to join the study.
  • Have stopped ER modulators (drugs that block estrogen's effects) for at least 8 weeks and ER down regulators (drugs that reduce estrogen receptors) for at least 28 weeks.
  • Be at least 18 years old.
  • Be fully active or able to do light work despite limits on hard physical activity.
  • Be expected to live at least 6 months.
  • Have radiation treatment planned for cancer that has spread to the brain.

Who can't join

  • Are pregnant.
  • Cannot receive standard care.
  • Are allergic to FES, the substance used for the study scan.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Active diagnosis of ER+ breast cancer (biopsy proven) and new or recurrent brain metastases (biopsy proven or suspected based on MRI appearance) 2. Ability to provide informed consent 3. Discontinuation of ER modulators for at least 8 weeks, and discontinuation of ER down regulators for at least 28 weeks (as per manufacturer guidelines) 4. Age \>=18 years 5. Eastern Cooperative Oncology Group performance score 0-1 6. Life expectancy \>=6 months 7. Planned for radiation treatment for brain metastases Exclusion Criteria: 1. Pregnancy 2. Unable to undergo Standard of Care 3. Allergy to FES.

Study sites (1)

NY