RecruitingPhase 2NCT06086704

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


Sponsor

University of Wisconsin, Madison

Enrollment

53 participants

Start Date

Sep 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria8

  • 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 Criteria19

  • 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.

Interventions

DRUG18F-fluorofuranylnorprogesterone

18F-FFNP will be given by a slow infusion (approximately 2 minutes), and the dose administered will be approximately 7 mCi.

DEVICEPositron Emissions Tomography / Magnetic Resonance Imaging

Breast specific PET/MRI data will be acquired using a 3T simultaneous PET/MRI scanner (Signa PET/MR, GE Healthcare)

DRUGAnastrozole

hormone based chemotherapy that reduces estrogen, 1 mg anastrozole once daily by mouth for a minimum of 14 days

OTHERBlood Sampling

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

DRUGFDA-approved gadolinium-based intravenous contrast agent

FDA-approved gadolinium-based intravenous contrast agent used for the MRI portion of this study


Locations(1)

UW Carbone Cancer Center

Madison, Wisconsin, United States

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NCT06086704


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