Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT06086704
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.
Study:
NCT06086704
Study Brief:
Protocol Section:
NCT06086704