Study of 18F-FFNP Breast PET/MRI
Phase II Study of 18F-FFNP Breast PET/MRI in the Assessment of Early Response of Breast Cancer to Presurgical Endocrine Therapy
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Primary Objective • Determine the diagnostic accuracy of 18F-FFNP PET/MRI for predicting response to presurgical endocrine therapy."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a breast PET/MRI scan using a radioactive tracer called 18F-FFNP can predict how well hormone treatment will work before surgery. It also checks how reliable the scan measurements are in people with newly diagnosed breast cancer that is PR-positive, meaning it has proteins that attach to progesterone.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Must be past menopause: both ovaries removed, or age 60 or older. For Group 2 only, people under 60 may qualify with no periods for at least 12 months and blood tests showing menopause, without past chemotherapy, tamoxifen, toremifene, or treatment to stop the ovaries from working.
- A biopsy must show invasive breast cancer, meaning cancer that has grown into nearby tissue. It must measure at least 1 cm on a scan and may be in the breast, underarm, or both.
- A biopsy must show PR-positive breast cancer, which has proteins that attach to progesterone.
- Group 2 only: Must plan surgery to remove the main tumor, with no treatment planned to shrink it before surgery.
Who can't join
- Cannot or do not want to give informed consent, or needed biopsy slides or tissue samples for PR and Ki67 tests are not available.
- Group 2 only: Have HER2-positive cancer, which has high levels of a growth-related protein, or have already completed chemotherapy, hormone treatment, targeted treatment, surgery, or radiation for this cancer.
- Plan to take anastrozole as usual treatment before surgery, or currently take aromatase inhibitors or estrogen-blocking drugs such as tamoxifen or raloxifene. These medicines affect hormones.
- Group 2 only: Have an allergy to anastrozole, or the study doctor says aromatase inhibitors are not safe for you.
- Have an allergy or another medical reason you cannot receive gadolinium, the MRI contrast dye, including kidney problems; or have had an allergic reaction to a substance similar to 18F-FFNP.
- Have breast expanders, are pregnant or breastfeeding, have liver failure, or have another medical reason you cannot have an MRI.
- Need sedation for the scan. Mild anxiety medicine taken by mouth is allowed only if you have your own prescription, give consent before taking it, and bring a driver.
- Cannot lie face down for 45 minutes for the scan.
Simplified for readability. The official criteria below are what the study team uses.
Official 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. 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) 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 (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) * 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
Study sites (1)
WI
- UW Carbone Cancer Center · Madison, WI 53792Roberta M Strigel, MD, MS · Sub-investigatorKari B Wisinski, MD · Sub-investigatorLee G Wilke, MD · Sub-investigatorScott B Perlman, MD · Sub-investigatorMore trials in Madison