Breast CancerPhase 2NCT06086704
Study of 18F-FFNP Breast PET/MRI
A Phase 2 study testing 18F-fluorofuranylnorprogesterone, Positron Emissions Tomography / Magnetic Resonance Imaging and Anastrozole in people with Breast Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 18F-fluorofuranylnorprogesterone, Positron Emissions Tomography / Magnetic Resonance Imaging and Anastrozole
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2024to 31 Aug 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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. Malignancy may be located within the breast, axilla (e.g. metastatic axillary lymph node), or both the breast and axilla
- Biopsy-proven PR-positive invasive breast cancer
- 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. (Group 2 only)
Who cannot join
- 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 (Group 2 only)
- 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)
Show all 19Show fewer
- Patients with breast expanders
- Patients who are pregnant or lactating
- Patients with clinical contraindication for use of aromatase inhibitors (AI) while on study as determined by investigator (Group 2 only)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UW Carbone Cancer Center
Madison, Wisconsin, 53792
Roberta M Strigel, MD, MS
Kari B Wisinski, MD
About this study
Official title: Phase II Study of 18F-FFNP Breast PET/MRI in the Assessment of Early Response of Breast Cancer to Presurgical Endocrine Therapy
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- 18F-fluorofuranylnorprogesterone, Positron Emissions Tomography / Magnetic Resonance Imaging, Anastrozole, Blood Sampling, FDA-approved gadolinium-based intravenous contrast agent
- Keywords
- PR+
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluorofuranylnorprogesteroneDrug
Also called FFNP
18F-FFNP will be given by a slow infusion (approximately 2 minutes), and the dose administered will be approximately 7 mCi.
Positron Emissions Tomography / Magnetic Resonance ImagingDevice
Also called PET/MRI
Breast specific PET/MRI data will be acquired using a 3T simultaneous PET/MRI scanner (Signa PET/MR, GE Healthcare)
AnastrozoleDrug
hormone based chemotherapy that reduces estrogen, 1 mg anastrozole once daily by mouth for a minimum of 14 days
Blood SamplingOther
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
FDA-approved gadolinium-based intravenous contrast agentDrug
Also called gadopiclenol, gadobenate dimuglumine
FDA-approved gadolinium-based intravenous contrast agent used for the MRI portion of this study
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Metabolite Analysis | Experimental | participants will undergo venous blood sampling during the PET/MRI scan Receives: Drug: 18F-fluorofuranylnorprogesterone; Device: Positron Emissions Tomography / Magnetic Resonance Imaging; Other: Blood Sampling; Drug: FDA-approved gadolinium-based intravenous contrast agent |
| Group 2: Pre-surgical Treatment | Experimental | participants will undergo PET/MRI scans before and after 2 weeks treatment with anastrozole Receives: Drug: 18F-fluorofuranylnorprogesterone; Device: Positron Emissions Tomography / Magnetic Resonance Imaging; Drug: Anastrozole; Drug: FDA-approved gadolinium-based intravenous contrast agent |
| Group 3: Test-Retest | Experimental | participants will undergo baseline and repeat PET/MRI scans without intervening treatment to determine repeatability Receives: Drug: 18F-fluorofuranylnorprogesterone; Device: Positron Emissions Tomography / Magnetic Resonance Imaging; Drug: FDA-approved gadolinium-based intravenous contrast agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in 18F-FFNP uptake between baseline and follow-up PET/MRI scans
Tumor uptake values of 18F-FFNP will be obtained from the attenuation corrected PET component of the simultaneous breast 18F-FFNP PET/MRI research scan according to the procedures detailed in the imaging manual and the FDA IND.
Measured: up to 4 weeks on study and up to 7 weeks on study
Percentage change in tumor Ki67 proliferation score, as a surrogate measure of endocrine sensitivity
Baseline Ki67 proliferation immunohistochemistry score will be obtained from the existing clinical standard-of-care breast biopsy. Post-treatment K67 proliferation immunohistochemistry score will be obtained from the surgical specimen after excision.
Treatment response is defined as a reduction in Ki67 score of greater than or equal to 60 percent. Treatment nonresponse is defined as a reduction of less than 60 percent.
Measured: up to 4 weeks on study and up to 7 weeks on study
Secondary outcomes (5)
Qualitative Analysis of 18F-FFNP uptake
18F-FFNP uptake will be visually evaluated qualitatively with the following grading scale: no uptake (tumor < background), minimal uptake (tumor = background), mild (tumor slightly > background), moderate uptake (tumor >> background), and intense uptake (tumor >>> background). Tumor uptake will also be dichotomized as increased (mild, moderate, or intense uptake) or absent (no uptake, minimal).
Measured: imaging takes up to 2 hours during a visit and will take place up to 4 weeks and up to 6 weeks for the test-retest Group 3
Intra- and Inter-Observer Variability of Quantitative Assessment of Tumor 18F-FFNP uptake
For the test-retest portion of the clinical trial, the mixed effects model framework will be utilized to determine the intra- and interobserver variability of quantitative assessment of tumor 18F-FFNP uptake via a parametric bootstrapping approach.
Measured: imaging takes up to 2 hours during a visit and will take place up to 4 weeks and up to 6 weeks for the test-retest Group 3
Quantitative Assessment of Tumor 18F-FFNP: Standardized Uptake Values (SUV)
Differences in repeatability of the different SUV measures (SUVmax, SUVpeak, and SUVmean) and their respective methods of normalization will be assessed by comparing the variances of the relative test-retest differences, using the Pitnam-Morgan test for correlated variances.
Measured: imaging takes up to 2 hours during a visit and will take place up to 4 weeks and up to 6 weeks for the test-retest Group 3
Test-Retest Variability of Quantitative Assessment of Tumor 18F-FFNP uptake
For the test-retest portion of the clinical trial, the mixed effects model framework will be utilized to determine the test-retest variability of quantitative assessment of tumor 18F-FFNP uptake via a parametric bootstrapping approach.
Measured: imaging takes up to 2 hours during a visit and will take place up to 4 weeks and up to 6 weeks for the test-retest Group 3
NCIC Adverse Events Version 5.0 Frequency Tables
Safety and tolerability of 18F-FFNP by NCIC Adverse Events Version 5.0 will be assessed by frequency tables and possible relationship to study drug as assessed by the investigators.
Measured: up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start25 Sep 2024
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Window of Opportunity
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Amy M Fowler, MD, PHD, Principal investigator, UW Carbone Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086704
- Sponsor's protocol ID
- 2023-1114
- Other IDs
- Protocol Version 7/30/2024, SMPH/RADIOLOGY/RADIOLOGY, UW23020, 1R01CA272571-01
- Status last verified
- Aug 2026
- First submitted
- 11 Oct 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of 18F-FFNP Breast PET/MRI in the Assessment of Early Response of Breast Cancer to Presurgical Endocrine Therapy
- ClinicalTrials.gov ID
- NCT06086704
- Acronym / sponsor ID
- 2023-1114
- Conditions
- Breast Cancer
- Keywords
- PR+
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Window of Opportunity
| Arm | Type | Receives |
|---|---|---|
| Group 1: Metabolite Analysis | Experimental | Drug: 18F-fluorofuranylnorprogesterone, Device: Positron Emissions Tomography / Magnetic Resonance Imaging, Other: Blood Sampling, Drug: FDA-approved gadolinium-based intravenous contrast agentparticipants will undergo venous blood sampling during the PET/MRI scan |
| Group 2: Pre-surgical Treatment | Experimental | Drug: 18F-fluorofuranylnorprogesterone, Device: Positron Emissions Tomography / Magnetic Resonance Imaging, Drug: Anastrozole, Drug: FDA-approved gadolinium-based intravenous contrast agentparticipants will undergo PET/MRI scans before and after 2 weeks treatment with anastrozole |
| Group 3: Test-Retest | Experimental | Drug: 18F-fluorofuranylnorprogesterone, Device: Positron Emissions Tomography / Magnetic Resonance Imaging, Drug: FDA-approved gadolinium-based intravenous contrast agentparticipants will undergo baseline and repeat PET/MRI scans without intervening treatment to determine repeatability |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Postmenopausal status defined by either
- Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.0 cm in diameter by any imaging modality. Malignancy may be located within the breast, axilla (e.g. metastatic axillary lymph node), or both the breast and axilla
- Biopsy-proven PR-positive invasive breast cancer
- 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. (Group 2 only)
Key exclusion criteria (19 listed)
- 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 (Group 2 only)
- Patients who are planning to undergo anastrozole as standard of care neoadjuvant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-fluorofuranylnorprogesteroneAlso: FFNP18F-FFNP will be given by a slow infusion (approximately 2 minutes), and the dose administered will be approximately 7 mCi. | Drug | Group 1: Metabolite Analysis, Group 2: Pre-surgical Treatment, Group 3: Test-Retest |
| Positron Emissions Tomography / Magnetic Resonance ImagingAlso: PET/MRIBreast specific PET/MRI data will be acquired using a 3T simultaneous PET/MRI scanner (Signa PET/MR, GE Healthcare) | Device | Group 1: Metabolite Analysis, Group 2: Pre-surgical Treatment, Group 3: Test-Retest |
| Anastrozolehormone based chemotherapy that reduces estrogen, 1 mg anastrozole once daily by mouth for a minimum of 14 days | Drug | Group 2: Pre-surgical Treatment |
| Blood SamplingVenous 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 | Other | Group 1: Metabolite Analysis |
| FDA-approved gadolinium-based intravenous contrast agentAlso: gadopiclenol, gadobenate dimuglumineFDA-approved gadolinium-based intravenous contrast agent used for the MRI portion of this study | Drug | Group 1: Metabolite Analysis, Group 2: Pre-surgical Treatment, Group 3: Test-Retest |
Primary outcome
Percentage change in 18F-FFNP uptake between baseline and follow-up PET/MRI scans
Time frame: up to 4 weeks on study and up to 7 weeks on study
Tumor uptake values of 18F-FFNP will be obtained from the attenuation corrected PET component of the simultaneous breast 18F-FFNP PET/MRI research scan according to the procedures detailed in the imaging manual and the FDA IND.
Percentage change in tumor Ki67 proliferation score, as a surrogate measure of endocrine sensitivity
Time frame: up to 4 weeks on study and up to 7 weeks on study
Baseline Ki67 proliferation immunohistochemistry score will be obtained from the existing clinical standard-of-care breast biopsy. Post-treatment K67 proliferation immunohistochemistry score will be obtained from the surgical specimen after excision. Treatment response is defined as a reduction in Ki67 score of greater than or equal to 60 percent. Treatment nonresponse is defined as a reduction of less than 60 percent.
5 secondary outcomes
Qualitative Analysis of 18F-FFNP uptake
Time frame: imaging takes up to 2 hours during a visit and will take place up to 4 weeks and up to 6 weeks for the test-retest Group 3
Intra- and Inter-Observer Variability of Quantitative Assessment of Tumor 18F-FFNP uptake
Time frame: imaging takes up to 2 hours during a visit and will take place up to 4 weeks and up to 6 weeks for the test-retest Group 3
Quantitative Assessment of Tumor 18F-FFNP: Standardized Uptake Values (SUV)
Time frame: imaging takes up to 2 hours during a visit and will take place up to 4 weeks and up to 6 weeks for the test-retest Group 3
Test-Retest Variability of Quantitative Assessment of Tumor 18F-FFNP uptake
Time frame: imaging takes up to 2 hours during a visit and will take place up to 4 weeks and up to 6 weeks for the test-retest Group 3
NCIC Adverse Events Version 5.0 Frequency Tables
Time frame: up to 7 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy M Fowler, MD, PHD principal investigator
UW Carbone Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-fluorofuranylnorprogesterone, Positron Emissions Tomography / Magnetic Resonance Imaging and Anastrozole in people with Breast Cancer, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Connect (800-622-8922, clinicaltrials@cancer.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in 18F-FFNP uptake between baseline and follow-up PET/MRI scans (time frame: up to 4 weeks on study and up to 7 weeks on study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.