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Study of 18F-FFNP Breast PET/MRI

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 7 months later Jan 2027 → Aug 31, 2028
See other at-risk trials from University of Wisconsin, Madison

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jan 2027 to Aug 31, 2028
    • Study completion pushed from Jan 2030 to Aug 31, 2030
    v16
  2. Eligibility criteria expanded, about 10 wordsv15
  3. Site contact updatedv14
  4. Start date changed from estimate of Oct 2024 to Sep 25, 2024
    • Site contact updated
    v13
  5. Interventions: 18F-fluorofuranylnorprogesterone (Drug), Anastrozole (Drug), Blood Sampling (Other), Gadobenate dimeglumine (Drug), Positron Emissions… to 18F-fluorofuranylnorprogesterone (Drug), Anastrozole (Drug), Blood Sampling (Other), FDA-approved gadolinium-based intravenous contrast…
    • Eligibility criteria expanded, about 12 words
    • Site contact updated
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Start date: Sep 2024 to Oct 2024
    • Site contact updated
    v11
  2. Start date: Aug 2024 to Sep 2024v10
  3. Start date: Jul 2024 to Aug 2024v9
  4. Start date: Jun 2024 to Jul 2024v8
  5. Start date: May 2024 to Jun 2024v7
  6. Start date: Apr 2024 to May 2024v6
  7. Start date: Mar 2024 to Apr 2024v5
  8. Start date: Feb 2024 to Mar 2024v4
  9. Start date: Jan 2024 to Feb 2024v3
  10. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This clinical trial will investigate an estrogen-regulated parameter as an early measure of endocrine therapy response: progesterone receptor (PR) protein with a progestin-based radioligand, 18F-fluorofuranylnorprogesterone (18F-FFNP). The overall purpose of this research is to test the efficacy of 18F-FFNP PET/MRI for predicting response to presurgical endocrine therapy and to determine the quantitative reliability of 18F-FFNP breast PET/MRI in patients with newly diagnosed PR+ primary breast cancer.
Trial Details
NCT Number NCT06086704
Lead Sponsor University of Wisconsin, Madison
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 53 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov