Trial Title:
Study of 18F-FFNP Breast PET/MRI
NCT ID:
NCT06086704
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Anastrozole
Conditions: Keywords:
PR+
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Window of Opportunity
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
18F-fluorofuranylnorprogesterone
Description:
18F-FFNP will be given by a slow infusion (approximately 2 minutes), and the dose
administered will be approximately 7 mCi.
Arm group label:
Group 1: Metabolite Analysis
Arm group label:
Group 2: Pre-surgical Treatment
Arm group label:
Group 3: Test-Retest
Other name:
FFNP
Intervention type:
Device
Intervention name:
Positron Emissions Tomography / Magnetic Resonance Imaging
Description:
Breast specific PET/MRI data will be acquired using a 3T simultaneous PET/MRI scanner
(Signa PET/MR, GE Healthcare)
Arm group label:
Group 1: Metabolite Analysis
Arm group label:
Group 2: Pre-surgical Treatment
Arm group label:
Group 3: Test-Retest
Other name:
PET/MRI
Intervention type:
Drug
Intervention name:
Anastrozole
Description:
hormone based chemotherapy that reduces estrogen, 1 mg anastrozole once daily by mouth
for a minimum of 14 days
Arm group label:
Group 2: Pre-surgical Treatment
Intervention type:
Other
Intervention name:
Blood Sampling
Description:
Venous blood samples will be collected at multiple timepoints (e.g., 5, 10, 20, 30, and
45 min after 18F-FFNP injection to determine parent and metabolite fractions
Arm group label:
Group 1: Metabolite Analysis
Intervention type:
Drug
Intervention name:
FDA-approved gadolinium-based intravenous contrast agent
Description:
FDA-approved gadolinium-based intravenous contrast agent used for the MRI portion of this
study
Arm group label:
Group 1: Metabolite Analysis
Arm group label:
Group 2: Pre-surgical Treatment
Arm group label:
Group 3: Test-Retest
Other name:
gadopiclenol
Other name:
gadobenate dimuglumine
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.
Criteria for eligibility:
Criteria:
Inclusion 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.
Exclusion Criteria:
- 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UW Carbone Cancer Center
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Roberta M Strigel, MD, MS
Contact backup:
Last name:
Kari B Wisinski, MD
Contact backup:
Last name:
Lee G Wilke, MD
Contact backup:
Last name:
Scott B Perlman, MD
Contact backup:
Last name:
Lonie R Salkowski, MD, MS, PhD
Contact backup:
Last name:
Aparna M Mahajan, MD
Contact backup:
Last name:
Stephanie M McGregor, MD, PhD
Contact backup:
Last name:
Emmanuel Sampene, PhD
Start date:
September 25, 2024
Completion date:
January 2030
Lead sponsor:
Agency:
University of Wisconsin, Madison
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Wisconsin, Madison
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06086704
