Clinical trial · Interventional
FFNP-PET/MR Imaging of Progesterone Receptor Expression in Invasive Breast Cancer
[18F]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging of Progesterone Receptor Expression in Invasive Breast Cancer
NCT03212170CI-TRIAL-00100037completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FFNP PET/MRI
- description
- 18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies.
- interventionNames
- Drug: [18F]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging
Primary outcomes (1)
- measure
- Correlation Coefficient Between FFNP Uptake and Allred Score
- timeFrame
- Up to 1 day
- description
- To compare FFNP uptake of biopsy-proven primary PR+ breast malignancies measured using PET/MRI with the reference standard of PR immunohistochemistry (IHC) using a semi-quantitative score obtained by using the Allred score (0-8; the higher the score, the more receptors were found). The correlation of the two measures will be evaluated with Pearson's correlation coefficient. The null hypothesis is H0: p0=0.50 and the alternative hypothesis is H1: p1 =0.75.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women 18 years of age or older * Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.0 cm in diameter by any imaging modality * Biopsy-proven PR-positive or PR-negative invasive breast cancer * Undergoing diagnostic breast MRI ordered by the referring clinician for staging and extent of disease Exclusion Criteria: * Inability or unwillingness to provide informed consent to the study * Participants currently undergoing neoadjuvant chemotherapy/endocrine therapy or those who have received chemotherapy/endocrine therapy within 6 months prior to the MRI * Participants who have had neoadjuvant chemotherapy/endocrine therapy, surgical intervention, or radiation for the current biopsy-proven malignancy * Participants with breast expanders * Participants who are or might be pregnant or lactating * Participants with a contraindication to gadolinium based contrast agents, including allergy or impaired renal function (per University of Wisconsin Health Guidelines) * Participants with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to FFNP * Participants in liver failure as judged by the patient's physician * 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: * The subject has their own prescription for the medication * The informed consent process is conducted prior to the self-administration of this medication * They come to the research visit with a driver * Participants unable to lie prone for 30 minutes for imaging
References
Publications (0)
Data not yet available
No reference posted for this study.