Trial Radar IA
Lo studio clinico NCT07434128 per Mammography Screening, Densità del seno è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
Un studio corrisponde ai criteri del filtro
Vista a schede
Torna alla ricerca

Mammogram Pretreatment With Ulipristal Acetate Fase II 26

Non ancora in arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07434128 è uno studio interventistico di Fase II volto a esaminare la diagnostica per Mammography Screening, Densità del seno, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 2 aprile 2026, con l'obiettivo di raggiungere 26 partecipanti. Sotto la guida di OHSU Knight Cancer Institute, dovrebbe concludersi entro il 31 dicembre 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 25 febbraio 2026.
Sommario breve
This phase II trial tests whether taking ulipristal acetate prior to a mammogram decreases breast density for people with a history of extremely 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...Mostra di più
Descrizione dettagliata
PRIMARY OBJECTIVE:

I. To evaluate change in percent dense area from antecedent to study screening mammograms.

SECONDARY OBJECTIVES:

I. To assess for menstrual cycle phase following this regimen of ulipristal acetate (UPA).

II. To assess adherence, tolerability and acceptability of the short course of UPA prior to a mammogram.

EXPLORATORY OBJECTIVES:

I. To determine the presence of radiographic changes in clinic...

Mostra di più
Titolo ufficiale

Progesterone Receptor Modulator Mammogram Pretreatment for Premenopausal People With a History of Extremely Dense Breast Tissue

Patologie
Mammography ScreeningDensità del seno
Altri ID dello studio
Numero NCT
NCT07434128
Data di inizio (effettiva)
2026-04-02
Ultimo aggiornamento pubblicato
2026-02-25
Data di completamento (stimata)
2027-12-31
Arruolamento (previsto)
26
Tipo di studio
Interventistico
FASE
Fase II
Stato
Non ancora in arruolamento
Parole chiave
Progesterone receptor modulators
Scopo principale
Diagnostico
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleDiagnostic (uliprostal acetate)
Patients receive ulipristal acetate PO every 5 days for 4 doses in the absence of unacceptable toxicity. Patients then undergo a mammogram. Patients also undergo MRI and blood sample collection throughout the study.
Raccolta di biospecimen
Undergo blood sample collection
Imaging a risonanza magnetica
Undergo MRI
Mammografia
Participants will undergo their standard of care mammogram.
Somministrazione del sondaggio
Ancillary studies
Ulipristal Acetate
Given orally
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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.
From baseline mammogram to study day 20 mammogram
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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.
At time of baseline MRI and at study day 20
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.
At time of baseline MRI and at study day 20
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.
At time of baseline MRI and at study day 20
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.
Study days 1, 5, 10 and 15.
Serum ulipristal acetate drug levels
Will be collected on the day of the mammogram following ulipristal acetate and presented descriptively (mean, standard deviation) and only confirm receipt of final dose of study drug.
Study day 20
Incidence of adverse events
Responses from these symptom surveys from first dose of study drug to the day of mammogram completed following ulipristal acetate will be aggregated and a binary variable will be generated to determine whether participants ever, or never, during the study period, reported each side effect/serious adverse events assessed in the surveys.
Study days 5, 10, 15 and 20
Acceptability of intervention
The frequency and proportion of participants rating the intervention as tolerable/acceptable will be reported and assessed descriptively.
Up to 7 days after study day 20
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto
Età minima
18 Years
Sessi idonei
Femmina
  • Participant or legally authorized representative (LAR) 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
  • Has an antecedent mammogram within 24 months with a Breast Imaging Reporting and Data System (BI-RADS) breast composition score of Category D (extremely dense) for which images are available for analysis
  • Report no history of breast cancer or symptoms concerning for breast cancer such as a self-palpated mass
  • Reasonably assumed to be premenopausal by history of regular menses. For individuals who do not menstruate (due to hysterectomy or endometrial ablation), premenopausal status will be determined clinically by the absence of symptoms of menopause including weekly hot flashes which is consistent with clinical care

  • 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
  • History of allergy to UPA
  • A history of liver disease (including but not limited to viral or autoimmune hepatitis, non-alcoholic fatty liver disease, hemochromatosis or Wilson's disease), alcoholism or a history of liver function tests such as aspartate aminotransferase (AST)/alanine aminotransferase (ALT) greater than 3 x the upper limit of normal without known etiology
  • Attempting pregnancy during the study duration or a positive urine pregnancy for people at risk of pregnancy who cannot be reasonably assumed not to be pregnant at the beginning of the intervention
  • Use of CYP3A4 inducer or inhibitors which may alter plasma concentrations of study drug (See Appendix A for list of common drugs/herbs). Regarding recent use of CYP3A4 inducers or inhibitors, a washout period will be deemed sufficient if at least 14 days or 5 half lives of the drug have elapsed prior to initiation of the study drug, whichever is longer. Participants will be advised to abstain from CYP3A4 inducers or inhibitors during the study and will only be ineligible if unable to
OHSU Knight Cancer Institute logoOHSU Knight Cancer Institute
National Cancer Institute (NCI) logoIstituto nazionale dei tumori, Estados Unidos
Parte responsabile dello studio
Abigail Liberty, Investigatore principale, Principal Investigator, OHSU Knight Cancer Institute
Nessun dato di contatto
1 Centri dello studio in 1 paesi

Oregon

OHSU Knight Cancer Institute, Portland, Oregon, 97239, United States
Abigail Liberty, Contatto, 503-494-3666, [email protected]
Abigail Liberty, Investigatore principale