Trial Outcomes & Findings for FFNP-PET/MR Imaging of Progesterone Receptor Expression in Invasive Breast Cancer (NCT NCT03212170)
NCT ID: NCT03212170
Last Updated: 2026-01-02
Results Overview
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.
COMPLETED
PHASE2
21 participants
Up to 1 day
2026-01-02
Participant Flow
Participants were enrolled from December 2017 to November 2024.
Participant milestones
| Measure |
FFNP PET/MRI
18F-Fluorofuranylnorprogesterone (FFNP) administration for Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) to assess biopsy-proven primary PR+ breast malignancies.
\[18F\]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging: 18F-Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging tracer
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
Analysis Population
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
FFNP PET/MRI
18F-Fluorofuranylnorprogesterone (FFNP) administration for Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) to assess biopsy-proven primary PR+ breast malignancies.
\[18F\]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging: 18F-Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging tracer
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
FFNP-PET/MR Imaging of Progesterone Receptor Expression in Invasive Breast Cancer
Baseline characteristics by cohort
| Measure |
FFNP PET/MRI
n=21 Participants
18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies.
\[18F\]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging: 18F-Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging tracer
|
|---|---|
|
Age, Customized
30-39 years
|
1 Participants
n=228 Participants
|
|
Age, Customized
40-49 years
|
3 Participants
n=228 Participants
|
|
Age, Customized
50-59 years
|
12 Participants
n=228 Participants
|
|
Age, Customized
60-69 years
|
4 Participants
n=228 Participants
|
|
Age, Customized
70-79 years
|
1 Participants
n=228 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=228 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=228 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=228 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=228 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=228 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=228 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=228 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=228 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=228 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=228 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=228 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=228 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=228 Participants
|
PRIMARY outcome
Timeframe: Up to 1 dayTo 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.
Outcome measures
| Measure |
FFNP PET/MRI
n=20 Participants
18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies.
\[18F\]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging: 18F-Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging tracer
|
FFNP PET/MRI (Re-test)
18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies.
|
|---|---|---|
|
Correlation Coefficient Between FFNP Uptake and Allred Score
|
0.3215 correlation coefficient (rho)
|
—
|
SECONDARY outcome
Timeframe: Up to 4 weeksPopulation: test-retest completed on a subset of the population, only 1 participant volunteered
Tumor uptake of FFNP and the ability to reproduce this measure, will be quantified in the 5 subjects who elect to undergo a second imaging session, using summary statistics of tumor FFNP uptake for each reading for PET/MRI. The analysis will be done separately for each reader.
Outcome measures
| Measure |
FFNP PET/MRI
n=1 Participants
18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies.
\[18F\]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging: 18F-Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging tracer
|
FFNP PET/MRI (Re-test)
n=1 Participants
18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies.
|
|---|---|---|
|
Test-Retest Reproducibility
|
NA SUVmax
Standard Deviation NA
Only 1 participant volunteered, data is insufficient to analyze test-retest reproducibility.
|
NA SUVmax
Standard Deviation NA
Only 1 participant volunteered, data is insufficient to analyze test-retest reproducibility.
|
SECONDARY outcome
Timeframe: Up to 4 weeksThe variability of observer assessment of tumor FFNP uptake will be measured. The intra- and inter-reader agreement of SUV values for tumor FFNP uptake will be analyzed with Bland-Altman plots and 95% limits of agreement. Analyses will be conducted on a per-lesion basis, and repeat tumors within the same patient will be assumed to be independent.
Outcome measures
| Measure |
FFNP PET/MRI
n=20 Participants
18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies.
\[18F\]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging: 18F-Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging tracer
|
FFNP PET/MRI (Re-test)
n=20 Participants
18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies.
|
|---|---|---|
|
Intra and Inter-Observer Assessment
|
2.76 SUVmax
Standard Deviation 1.536
|
2.629 SUVmax
Standard Deviation 1.568
|
SECONDARY outcome
Timeframe: Up to 4 weeksEstimate the association of tumor FFNP uptake (continuous SUVmax) with research-based Oncotype DX scores (0-100). The risk score (0-100) is generated from expression levels of sixteen cancer related genes and five reference genes. Scores are further categorized as low-risk (0-17), intermediate-risk (18-30), and high-risk (31-100). Pearson's or Spearman's rank correlation will be used to evaluate the association between FFNP uptake and research-based Oncotype DX score. The correlation coefficient (rho) and 95% confidence interval will be reported.
Outcome measures
| Measure |
FFNP PET/MRI
n=20 Participants
18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies.
\[18F\]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging: 18F-Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging tracer
|
FFNP PET/MRI (Re-test)
18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies.
|
|---|---|---|
|
Correlation Coefficient Between Tumor FFNP Uptake With Oncotype DX Score
|
-0.377 correlation coefficient (rho)
Interval -0.797 to 0.2873
|
—
|
SECONDARY outcome
Timeframe: up to 4 weeksTo evaluate the optimal cut-point of FFNP uptake for distinguishing between PR-negative and PR-positive invasive breast cancer. Receiver operating characteristic (ROC) curve analysis will be performed to determine the optimal cut-point for FFNP uptake to distinguish PR-positive from PR-negative invasive breast cancer, as defined by the clinical pathology report. The AUC for the ROCs and their respective two-sided 95% confidence intervals will be calculated using logistic regression. The optimal cut-off point will be determined by considering the FFNP uptake value with the maximum sensitivity and specificity. The analysis will be done separately for each reader, AUC is reported here.
Outcome measures
| Measure |
FFNP PET/MRI
n=20 Participants
18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies.
\[18F\]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging: 18F-Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging tracer
|
FFNP PET/MRI (Re-test)
n=20 Participants
18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies.
|
|---|---|---|
|
Distinguishing Between PR Negative and PR Positive Breast Cancer Reported as Area Under the Curve (AUC)
|
0.80 probability
Interval 0.361 to 0.99
|
0.70 probability
Interval 0.47 to 0.93
|
SECONDARY outcome
Timeframe: up to 4 weeksTo evaluate the optimal cut-point of FFNP uptake for distinguishing between PR-negative and PR-positive invasive breast cancer. Receiver operating characteristic (ROC) curve analysis will be performed to determine the optimal cut-point for FFNP uptake to distinguish PR-positive from PR-negative invasive breast cancer, as defined by the clinical pathology report. The AUC for the ROCs and their respective two-sided 95% confidence intervals will be calculated using logistic regression. The optimal cut-off point will be determined by considering the FFNP uptake value with the maximum sensitivity and specificity. The analysis will be done separately for each reader, optimal cut point is reported here.
Outcome measures
| Measure |
FFNP PET/MRI
n=20 Participants
18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies.
\[18F\]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging: 18F-Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging tracer
|
FFNP PET/MRI (Re-test)
n=20 Participants
18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies.
|
|---|---|---|
|
Distinguishing Between PR Negative and PR Positive Breast Cancer Reported as Optimal Cut Point
|
1.96 SUVmax
|
1.96 SUVmax
|
Adverse Events
FFNP PET/MRI
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FFNP PET/MRI
n=20 participants at risk
18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies.
\[18F\]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging: 18F-Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging tracer
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
5.0%
1/20 • up to 24 hours
Adverse events occurring within 24 hours after FFNP infusion will be recorded by the study coordinator who will contact the subject within 1 to 3 days after FFNP administration.
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • up to 24 hours
Adverse events occurring within 24 hours after FFNP infusion will be recorded by the study coordinator who will contact the subject within 1 to 3 days after FFNP administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place