WITHDRAWN

Pilot Study to Evaluate if Contrast Enhanced Ultrasound (CEUS) Can Predict Treatment Response in Triple Negative Breast Cancer (TNBC) Patients Receiving Combined Chemotherapy and Immune Checkpoint Inhibitors (ICI).

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Conditions

Breast CancerContrast Enhanced Ultrasound

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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

To find out if contrast enhanced ultrasound (CEUS) can be used to determine if patients receiving combined ICI therapy for triple negative breast cancer (TNBC) are responding to treatment earlier than standard of care MR or CT.

Official Title

Pilot Study to Evaluate if Contrast Enhanced Ultrasound (CEUS) Can Predict Treatment Response in Triple Negative Breast Cancer (TNBC) Patients Receiving Combined Chemotherapy and Immune Checkpoint Inhibitors (ICI).

Quick Facts

Study Start:2023-09-01
Study Completion:2031-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:WITHDRAWN

Study ID

NCT05957042

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. * Willingness and ability to sign and date the study-specific informed consent form.
  2. * Stated willingness to comply with all study procedures and attend all study visits to the best of his or her ability for the duration of the study.
  3. * Age greater than 18yo.
  4. * Stage I-III TNBC or stage IV TNBC with intact breast primary.
  5. * Planned combined ICI therapy as per SoC by treating oncologist.
  1. * Other clinical trials are not excluded but participation must be cleared with the other clinical trial PIs.
  2. * Patients not suitable to undergo contrast enhanced ultrasound (i.e., pregnant women, known allergy to eggs, or a past allergic reaction to sonographic contrast or its components, such as polyethylene glycol (PEG))

Contacts and Locations

Principal Investigator

Seth Hardy, M.D.
PRINCIPAL_INVESTIGATOR
Assistant Professor - Department of Radiology, Penn State Health

Study Locations (Sites)

Penn State Health College of Medicine
Hershey, Pennsylvania, 17033
United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

  • Seth Hardy, M.D., PRINCIPAL_INVESTIGATOR, Assistant Professor - Department of Radiology, Penn State Health

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 Date2023-09-01
Study Completion Date2031-09-01

Study Record Updates

Study Start Date2023-09-01
Study Completion Date2031-09-01

Terms related to this study

Keywords Provided by Researchers

  • Breast Cancer
  • Contrast Enhanced Ultrasound

Additional Relevant MeSH Terms

  • Breast Cancer
  • Contrast Enhanced Ultrasound