For Healthcare Professionals

FFNP-PET/MR Imaging of Progesterone Receptor Expression in Invasive Breast Cancer

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About the study

The goal of this research is to test the accuracy of PET/MRI imaging with 18F-fluorofuranylnorprogesterone (FFNP) for measuring progesterone receptor (PR) expression in patients with invasive breast cancer. The hypothesis is that FFNP SUVmax from PET/MRI will correlate well against the semi-quantitative PR immunohistochemistry score.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Women 18 years of age or older
  2. Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.0 cm in diameter by any imaging modality
  3. Biopsy-proven PR-positive (N=23) or PR-negative (N=5) invasive breast cancer
  4. Undergoing diagnostic breast MRI ordered by the referring clinician for staging and extent of disease

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Inability or unwillingness to provide informed consent to the study
  2. Participants currently undergoing neoadjuvant chemotherapy/endocrine therapy or those who have received chemotherapy/endocrine therapy within 6 months prior to the MRI
  3. Participants who have had neoadjuvant chemotherapy/endocrine therapy, surgical intervention, or radiation for the current biopsy-proven malignancy
  4. Participants with breast expanders
  5. Participants who are or might be pregnant or lactating
  6. Participant girth exceeds the bore of the PET/MRI scanner
  7. Participants with a contraindication to gadolinium based contrast agents, including allergy or impaired renal function (per University of Wisconsin Health Guidelines)
  8. Participants with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to FFNP
  9. Participants in liver failure as judged by the patient's physician
  10. Participants with standard contraindications to MRI, including claustrophobia and metallic implants incompatible with MRI

Participants requiring intravenous (IV) conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:

  1. The subject has their own prescription for the medication
  2. The informed consent process is conducted prior to the self-administration of this medication
  3. They come to the research visit with a driver
  4. Participants unable to lie prone for 30 minutes for imaging
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 608-262-7269Email iconEmail Study Center

Study’s details


Contition

Invasive Breast Cancer

Age (in years)

18+

Phase

Phase 2

Participants needed

21

Est. Completion Date

Dec 31, 2024

Treatment type

Interventional


Sponsor

University of Wisconsin, Madison

ClinicalTrials.gov identifier

NCT03212170

Study number

20170533

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