Early Phase 1 Breast Cancer Trial, Recruiting NCT05291507 Sponsor: University of Utah Condition: Breast Cancer
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Early Phase 1 Breast Cancer Trial, Recruiting

NCT05291507
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who can speak and understand English.
  • Women aged 18 or older who have invasive breast cancer and are scheduled for surgery.
  • People who are generally able to carry out daily activities with little to no limitation (confirm with trial site).
  • People assessed as being in good to very good general health before an anaesthetic, based on a standard medical classification scale.
  • People whose breast size is considered suitable for the MUSE device, as assessed by a doctor before the study begins.
  • People who are willing and able to give informed consent by signing an approved consent form.
  • People with kidneys that are functioning well enough, based on a standard blood test result (confirm with trial site).
  • Women who could become pregnant must agree to use a highly effective method of contraception as outlined by the trial.
  • Women who have a negative pregnancy test, or who have evidence of being post-menopausal, or who have had a permanent surgical procedure such as removal of both ovaries, both fallopian tubes, or the uterus. Post-menopausal status has specific requirements depending on age (confirm details with trial site).

Who may not be able to join:

  • People who are already taking part in another clinical trial at the time of registering for this study.
  • People who have previously received systemic cancer treatment or any investigational therapy for breast cancer before surgery.
  • People who have previously had radiation therapy to the same breast now affected by cancer.
  • People diagnosed with another cancer within the last 2 years, unless that cancer has been fully treated with no remaining signs or symptoms and will not need further treatment during this study (some low-risk cancers may be considered after discussion with the lead doctor).
  • Women who have breast implants.
  • Women who are pregnant or currently breastfeeding.
  • People who are unable to lie face-down for 90 minutes, either as reported by the person themselves or as determined by the doctor.
  • People who have previously had a severe allergic or adverse reaction to commonly used sedative medications such as midazolam or propofol.
  • People who have previously had a severe allergic or adverse reaction to gadolinium contrast dye used in MRI scans.
  • People for whom an MRI scan is not safe or suitable, as determined by their treating doctor or based on their answers to an MRI safety questionnaire.
  • People whose medical, psychiatric, cognitive, or other conditions may affect their ability to understand the study, give consent, or follow the study requirements, in the opinion of the investigator.
  • For one specific group in the trial (Cohort 1 only): people whose tumour is classified as grade 3, or where only a very small amount of invasive tumour was found in the biopsy sample, or where HER2 test results from the biopsy are unclear after multiple types of testing, or where there is concern about how the biopsy sample was handled or processed.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Cindy Matsen, MD, Huntsman Cancer Institute

Phone: 801-585-0571

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Registry
ClinicalTrials.gov
Start date
23 January 2023
Est. completion
1 January 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

frequency of adverse events (AEs), adverse device effects (ADEs), and serious adverse events (SAEs) characterized by type; frequency of adverse events (AEs), adverse device effects (ADEs), and serious adverse events (SAEs) characterized by severity (as defined by the NCI CTCAE, version 5.0); frequency of adverse events (AEs), adverse device effects (ADEs), and serious adverse events (SAEs) characterized by seriousness; frequency of adverse events (AEs), adverse device effects (ADEs), and serious adverse events (SAEs) characterized by duration; frequency of adverse events (AEs), adverse device...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov