RECRUITING

Study of Screening Brain MRIs in Stage IV Breast Cancer

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Conditions

Triple Negative Breast CancerHER2-positive Breast CancerHormone Receptor-positive Breast CancerStage IV Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.

Official Title

Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer

Quick Facts

Study Start:2021-12-21
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05115474

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status
  2. * Radiographic evidence of stage IV extracranial diease having progressed past first line therapy in HR+/HER2- patients
  3. * Radiographic evidence of stage IV extracranial disease in TN and HER2+ patients
  4. * Age ≥ 18
  5. * Life expectancy ≥ 6 months
  6. * Eastern Cooperative Oncology Group performance status 0 to 2
  7. * Patients must be able to understand and the willingness to sign an informed consent for study procedures
  8. * Stated willingness to comply with all study procedures and availability for the duration of the study
  1. * Prior diagnosis or treatment of brain metastases or leptomeningeal disease
  2. * Patients with prior history of non-breast cancer malignancies should have no evidence of disease ≥ 2 years
  3. * Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment
  4. * Indications warranting brain MRI for other neurologic conditions at time of study entry
  5. * Contraindication towards MRI imaging with contrast
  6. * Chronic kidney disease stage IV or V or end stage renal disease

Contacts and Locations

Study Contact

Robin Dowell
CONTACT
813-745-0393
Robin.Dowell@moffitt.org

Principal Investigator

Kamran A Ahmed, MD
PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center

Study Locations (Sites)

Morton Plant Mease- Baycare
Clearwater, Florida, 33756
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

  • Kamran A Ahmed, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-21
Study Completion Date2026-06

Study Record Updates

Study Start Date2021-12-21
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • Stage IV Breast Cancer

Additional Relevant MeSH Terms

  • Triple Negative Breast Cancer
  • HER2-positive Breast Cancer
  • Hormone Receptor-positive Breast Cancer