Health TrialsbyHealthPanel

Mammogram Pretreatment With Ulipristal Acetate

ConditionsMammography ScreeningBreast Density
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorOHSU Knight Cancer Institute

About this trial

This phase II trial tests whether taking ulipristal acetate prior to a mammogram decreases breast density for people with a history of dense breast tissue. One limitation to breast cancer screening with mammography is dense breast tissue, which decreases the sensitivity of screening as breast density masks cancer and precancerous lesions. Ulipristal acetate lowers the amount of progesterone made by the body which may temporarily decrease the density of the breast tissue, allowing for a more accurate mammogram for people with dense breast tissue.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant must provide written informed consent before any study-specific procedures or interventions are performed

Ages 18-50 years. The maximum age cut off is due to the intervention only applying to premenopausal physiology only

Assigned female at birth with at least one ovary in situ. Members of all races and ethnic groups will be included

Presenting for a screening mammogram

Disqualifiers

Having a mammogram as part of a diagnostic process

Current breast implants in one or both breasts

Pregnant, less than 1 year postpartum or breastfeeding within last 6 months at the time of their antecedent mammogram or their current mammogram. This exclusion is due to known changes in mammograms during pregnancy and postpartum that would preclude comparative analyses

Using hormonal medications including estrogens or progestins

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Mammogram

    Procedure/Surgery

    Participants will undergo their standard of care mammogram.

  • Survey Administration

    Other intervention

    Ancillary studies

  • Ulipristal Acetate

    Drug

    Given orally

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: Diagnostic (ulipristal acetate)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Difference in percent dense area

DEEP-Libra will be utilized to obtain the change in breast percent density value per patient between the historical baseline mammogram and mammogram following ulipristal acetate. Both images (baseline and mammogram following ulipristal acetate) will be independently analyzed with DEEP-Libra to generate the percent dense area and then the mean difference will be recorded. The mean and standard deviation of the difference in percent dense area between the baseline and mammogram following ulipristal acetate will be reported.

Time frame
From baseline mammogram to study day 20 mammogram

Secondary outcomes

1

Progesterone level

Each participant will be categorized as being in their luteal phase, follicular phase, or as experiencing imminent ovulation at the time of both breast magnetic resonance imagings (MRI): at baseline and immediately after completion of the study drug. The frequency and proportion of participants in each category will be reported and assessed descriptively, as well as median and range, or mean and standard deviation.

Time frame
At time of baseline MRI and at study day 20
2

Estradiol level

Each participant will be categorized as being in their luteal phase, follicular phase, or as experiencing imminent ovulation at the time of both breast MRIs: at baseline and immediately after completion of the study drug. The frequency and proportion of participants in each category will be reported and assessed descriptively, as well as median and range, or mean and standard deviation.

Time frame
At time of baseline MRI and at study day 20
3

Luteinizing hormone level

Each participant will be categorized as being in their luteal phase, follicular phase, or as experiencing imminent ovulation at the time of both breast MRIs: at baseline and immediately after completion of the study drug. The frequency and proportion of participants in each category will be reported and assessed descriptively, as well as median and range, or mean and standard deviation.

Time frame
At time of baseline MRI and at study day 20
4

Patient reported doses and deviations greater than 24 hours from recommended doses

Administration of the study drug and deviations of the study drug administration greater than 24 hours will be described and utilized for determination of study population from the first dose of the study drug to the day of the mammogram following ulipristal acetate.

Time frame
Study days 1, 5, 10 and 15.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OHSU Knight Cancer Institute

Lead sponsor

Oregon Health and Science University

Collaborator

Source ClinicalTrials.gov
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