Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT06086704
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2023-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of 18F-FFNP Breast PET/MRI
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Phase II Study of 18F-FFNP Breast PET/MRI in the Assessment of Early Response of Breast Cancer to Presurgical Endocrine Therapy
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
Primary Objective
• Determine the diagnostic accuracy of 18F-FFNP PET/MRI for predicting response to presurgical endocrine therapy.
Secondary Objectives
* Determine the repeatability of quantitative assessment of tumor 18F-FFNP uptake.
* Determine the intra- and inter-observer variability of quantitative assessment of tumor 18F-FFNP uptake.
* Assess the safety and tolerability of 18F-FFNP.
Exploratory Objectives
* Define the parent and metabolite fractions of 18F-FFNP over the time course of the scan.
* Assess the association between tumor 18F-FFNP uptake with serum progesterone, estradiol, and corticosteroid binding globulin levels.
* Compare changes in 18F-FFNP breast PET/MRI parameters with changes in PR immunohistochemistry in therapy responders and non-responders.
* Assess the association between tumor 18F-FFNP uptake with disease recurrence.
* Determine whether MRI parameters improve the predictive value of FFNP PET alone.
• Determine the diagnostic accuracy of 18F-FFNP PET/MRI for predicting response to presurgical endocrine therapy.
Secondary Objectives
* Determine the repeatability of quantitative assessment of tumor 18F-FFNP uptake.
* Determine the intra- and inter-observer variability of quantitative assessment of tumor 18F-FFNP uptake.
* Assess the safety and tolerability of 18F-FFNP.
Exploratory Objectives
* Define the parent and metabolite fractions of 18F-FFNP over the time course of the scan.
* Assess the association between tumor 18F-FFNP uptake with serum progesterone, estradiol, and corticosteroid binding globulin levels.
* Compare changes in 18F-FFNP breast PET/MRI parameters with changes in PR immunohistochemistry in therapy responders and non-responders.
* Assess the association between tumor 18F-FFNP uptake with disease recurrence.
* Determine whether MRI parameters improve the predictive value of FFNP PET alone.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Protocol Version 7/30/2024 | OTHER | UW Madison | View | |
| SMPH/RADIOLOGY/RADIOLOGY | OTHER | UW Madison | View | |
| UW23020 | OTHER | UWCCC OnCore ID | View | |
| 1R01CA272571-01 | NIH | None | https://reporter.nih.gov/quic… | View |