RECRUITING

Study of 18F-FFNP Breast PET/MRI

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase II Study of 18F-FFNP Breast PET/MRI in the Assessment of Early Response of Breast Cancer to Presurgical Endocrine Therapy

Quick Facts

Study Start:2024-09-25

Study Completion:2030-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06086704

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Postmenopausal status defined by either * prior bilateral oophorectomy * age greater than or equal to 60 years of age * age less than 60 years of age and amenorrheic for 12 or more months in the absence of prior chemotherapy, tamoxifen, toremifene or ovarian suppression and FSH and estradiol in the postmenopausal range per local normal range (Group 2 only) * Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.0 cm in diameter by any imaging modality * Biopsy-proven PR-positive invasive breast cancer * Breast MRI planned or performed before surgery * Definitive surgical excision of the primary tumor planned without neoadjuvant therapy; defined as therapy (chemotherapy, targeted therapy, radiation therapy or endocrine therapy) given to decrease the size of the tumor prior to planned surgery.	* Inability or unwillingness to provide informed consent to the study * HER2-positive breast cancer, as defined by immunohistochemical staining 3+ OR positive by in situ hybridization (Group 2 only) * PR and Ki67 IHC slides or FFPE tissue blocks from clinical breast biopsy not available * Patients who have completed neoadjuvant chemotherapy, endocrine therapy, targeted therapy, surgical resection, or radiation for the current biopsy-proven malignancy * Patients who are planning to undergo anastrozole as standard of care neoadjuvant therapy * Patients who are currently taking aromatase inhibitors or ER antagonists (tamoxifen, raloxifene) * Patients with breast expanders * Patients who are pregnant or lactating * Patients with a contraindication to gadolinium-based contrast agents, including allergy or impaired renal function (per UW Health Guidelines) * Patients with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FFNP * Patients with history of allergic reaction to anastrozole (Group 2 only) * Patients in liver failure as judged by the patient's physician * Patients with standard contraindications to MRI (per UW Health Guidelines) * Patients requiring conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the clinical MRI scan will be allowed to participate as long as the following criteria are met: * The patient has their own prescription for the medication * The informed consent process is conducted prior to the self-administration of the medication. * The patient comes to the research visit with a driver. * Patients unable to lie prone for 45 minutes for imaging * Patients taking hormone replacement therapy or over-the-counter products/supplements/herbal preparation with potential estrogenic effects who are unwilling to discontinue these agents during the timeframe of the study until surgery.

Inclusion Criteria

Exclusion Criteria

* Postmenopausal status defined by either
* prior bilateral oophorectomy
* age greater than or equal to 60 years of age
* age less than 60 years of age and amenorrheic for 12 or more months in the absence of prior chemotherapy, tamoxifen, toremifene or ovarian suppression and FSH and estradiol in the postmenopausal range per local normal range (Group 2 only)
* Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.0 cm in diameter by any imaging modality
* Biopsy-proven PR-positive invasive breast cancer
* Breast MRI planned or performed before surgery
* Definitive surgical excision of the primary tumor planned without neoadjuvant therapy; defined as therapy (chemotherapy, targeted therapy, radiation therapy or endocrine therapy) given to decrease the size of the tumor prior to planned surgery.

* Inability or unwillingness to provide informed consent to the study
* HER2-positive breast cancer, as defined by immunohistochemical staining 3+ OR positive by in situ hybridization (Group 2 only)
* PR and Ki67 IHC slides or FFPE tissue blocks from clinical breast biopsy not available
* Patients who have completed neoadjuvant chemotherapy, endocrine therapy, targeted therapy, surgical resection, or radiation for the current biopsy-proven malignancy
* Patients who are planning to undergo anastrozole as standard of care neoadjuvant therapy
* Patients who are currently taking aromatase inhibitors or ER antagonists (tamoxifen, raloxifene)
* Patients with breast expanders
* Patients who are pregnant or lactating
* Patients with a contraindication to gadolinium-based contrast agents, including allergy or impaired renal function (per UW Health Guidelines)
* Patients with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FFNP
* Patients with history of allergic reaction to anastrozole (Group 2 only)
* Patients in liver failure as judged by the patient's physician
* Patients with standard contraindications to MRI (per UW Health Guidelines)
* Patients requiring conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the clinical MRI scan will be allowed to participate as long as the following criteria are met:
* The patient has their own prescription for the medication
* The informed consent process is conducted prior to the self-administration of the medication.
* The patient comes to the research visit with a driver.
* Patients unable to lie prone for 45 minutes for imaging
* Patients taking hormone replacement therapy or over-the-counter products/supplements/herbal preparation with potential estrogenic effects who are unwilling to discontinue these agents during the timeframe of the study until surgery.

Contacts and Locations

Study Contact

Cancer Connect

CONTACT

800-622-8922

clinicaltrials@cancer.wisc.edu

Principal Investigator

Amy M Fowler, MD, PHD

PRINCIPAL_INVESTIGATOR

UW Carbone Cancer Center

Study Locations (Sites)

UW Carbone Cancer Center

Madison, Wisconsin, 53792

United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

Amy M Fowler, MD, PHD, PRINCIPAL_INVESTIGATOR, UW Carbone Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-25

Study Completion Date2030-01

Study Record Updates

Study Start Date2024-09-25

Study Completion Date2030-01

Terms related to this study

Keywords Provided by Researchers

Additional Relevant MeSH Terms

Breast Cancer