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FFNP-PET/MR Imaging for Breast Cancer
Phase 2
Recruiting
Led By Amy Fowler, MD, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.0 cm in diameter by any imaging modality
Biopsy-proven PR-positive (N=23) or PR-negative (N=5) invasive breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks
Awards & highlights
Study Summary
This trial is testing whether a PET/MRI using a certain tracer can accurately measure the amount of a protein in breast cancer patients.
Who is the study for?
This trial is for women over 18 with invasive breast cancer that's at least 1 cm big, as seen on any imaging test. They must be getting a diagnostic MRI and have PR-positive or PR-negative breast cancer. It's not for those who can't lie prone for the scan, have liver failure, MRI contraindications like claustrophobia or certain implants, allergies to FFNP or gadolinium contrast agents, recent neoadjuvant therapy/surgery/radiation, are pregnant/lactating, exceed the scanner size limit, or have breast expanders.Check my eligibility
What is being tested?
The study tests if PET/MRI scans using a tracer called [18F]Fluorofuranylnorprogesterone (FFNP) can accurately measure progesterone receptor levels in invasive breast cancer. The idea is that the maximum signal from FFNP on the scan will match up well with lab scores of hormone receptor status.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to FFNP similar to other compounds in its class. Since it involves an MRI scan with contrast agent use (gadolinium), there could also be risks related to allergies or kidney issues from the contrast.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is confirmed by biopsy and measures at least 1.0 cm.
Select...
My breast cancer is confirmed by biopsy to be either PR-positive or PR-negative.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
FFNP Uptake
Secondary outcome measures
Association of tumor FFNP uptake with Oncotype DX score
Distinguishing between PR Negative and PR Positive Breast Cancer
Intra and Inter-Observer Assessment
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: FFNP PET/MRIExperimental Treatment1 Intervention
18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies.
Find a Location
Who is running the clinical trial?
National Center for Advancing Translational Sciences (NCATS)NIH
321 Previous Clinical Trials
401,728 Total Patients Enrolled
4 Trials studying Breast Cancer
1,866 Patients Enrolled for Breast Cancer
University of Wisconsin, MadisonLead Sponsor
1,183 Previous Clinical Trials
3,167,950 Total Patients Enrolled
36 Trials studying Breast Cancer
38,519 Patients Enrolled for Breast Cancer
Amy Fowler, MD, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot lie on my stomach for 30 minutes.Your body is too big to fit inside the PET/MRI scanner.You have breast expanders.I am currently on or recently had chemotherapy or hormone therapy.My doctor has diagnosed me with liver failure.I have received treatments like chemotherapy, surgery, or radiation for my current cancer.My breast cancer is confirmed by biopsy and measures at least 1.0 cm.You cannot have an MRI because you are claustrophobic or have metal implants that are not safe for MRI.My breast cancer is confirmed by biopsy to be either PR-positive or PR-negative.I am a woman aged 18 or older.I cannot use gadolinium contrast due to an allergy or kidney issues.I am scheduled for a breast MRI to check the stage and spread of my cancer.You have had an allergic reaction to drugs that are similar to FFNP.I can undergo MRI without IV sedation but may take my prescribed anxiety medication with a driver present.
Research Study Groups:
This trial has the following groups:- Group 1: FFNP PET/MRI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA recognize [18F]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging?
"[18F]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging is currently being trialed in Phase 2. This suggests that while there is some evidence backing the safety of this imaging method, its efficacy has not yet been clinically proven."
Answered by AI
Are we still able to sign up for this research study?
"From what is posted on clinicaltrials.gov, it appears that this trial is still open and looking for patients. The listing was first put up on December 13th, 2017 with the latest update being from December 16th, 2021."
Answered by AI
How many total participants are needed for this clinical trial?
"Yes, this study is still open to eligible participants. The trial was initially posted on December 13th, 2017 and was last updated on December 16th, 2021. A total of 28 patients will be enrolled from 1 site."
Answered by AI
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