Trial Outcomes & Findings for Hybrid Molecular Imaging of ER in Breast Cancer Patients With DCIS (NCT NCT03703492)

Last Updated: 2025-02-12

Results Overview

18F-FES uptake of biopsy-proven ductal carcinoma in situ (DCIS) measured using PET/MRI will be reported in Standardized Uptake Values (SUV).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

1 day

Results posted on

2025-02-12

Participant Flow

Participants were enrolled at UW Health from January 2019 to December 2023.

Participant milestones

Participant milestones
Measure	Research Arm Directed breast PET/MRI with 18F-FES; 18F-FES uptake of the known malignancy to be measured on the PET/MRI examination (18F)FES: 18F-FES is an investigational new drug which will be used for this study. For complete information, please refer to the Investigator's Brochure: "\[18F\]Fluoroestradiol: An investigational positron emission tomography (PET) radiopharmaceutical for injection, intended for use as an in vivo diagnostic for imaging estrogen receptors in tumors Gadobenate dimeglumine: Gadolinium-based intravenous contrast agent used for the MRI portion of this study
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hybrid Molecular Imaging of ER in Breast Cancer Patients With DCIS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Research Arm n=12 Participants Directed breast PET/MRI with 18F-FES; 18F-FES uptake of the known malignancy to be measured on the PET/MRI examination (18F)FES: 18F-FES is an investigational new drug which will be used for this study. For complete information, please refer to the Investigator's Brochure: "\[18F\]Fluoroestradiol: An investigational positron emission tomography (PET) radiopharmaceutical for injection, intended for use as an in vivo diagnostic for imaging estrogen receptors in tumors Gadobenate dimeglumine: Gadolinium-based intravenous contrast agent used for the MRI portion of this study
Age, Customized 40 to 49 years old	5 Participants n=5 Participants
Age, Customized 50 to 59 years old	5 Participants n=5 Participants
Age, Customized 60 to 69 years old	2 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

18F-FES uptake of biopsy-proven ductal carcinoma in situ (DCIS) measured using PET/MRI will be reported in Standardized Uptake Values (SUV).

Outcome measures

Outcome measures
Measure	Research Arm n=12 Participants Directed breast PET/MRI with 18F-FES; 18F-FES uptake of the known malignancy to be measured on the PET/MRI examination (18F)FES: 18F-FES is an investigational new drug which will be used for this study. For complete information, please refer to the Investigator's Brochure: "\[18F\]Fluoroestradiol: An investigational positron emission tomography (PET) radiopharmaceutical for injection, intended for use as an in vivo diagnostic for imaging estrogen receptors in tumors Gadobenate dimeglumine: Gadolinium-based intravenous contrast agent used for the MRI portion of this study
18F-FES Uptake in DCIS	1.43 SUV Standard Deviation 0.83

SECONDARY outcome

Timeframe: 2 months

Population: Data for low-risk DCIS is insufficient to perform ROC curve analysis.

ROC curve analysis will be performed to determine the optimal cut-point for 18F-FES SUVmax to distinguish low-risk DCIS and intermediate/high-risk DCIS. Risk categories will be determined using the Van Nuys Prognostic Index, the Memorial Sloan-Kettering Cancer Center Nomogram, and the research-based Oncotype DX DCIS score. Sensitivity and specificity will be determined with two-sided 95% confidence intervals. The area under the curve (AUCs) 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 18F-FES uptake value with the maximum sensitivity and specificity. This analysis will be done separately for each risk assessment model.

Outcome measures

Outcome measures
Measure	Research Arm n=12 Participants Directed breast PET/MRI with 18F-FES; 18F-FES uptake of the known malignancy to be measured on the PET/MRI examination (18F)FES: 18F-FES is an investigational new drug which will be used for this study. For complete information, please refer to the Investigator's Brochure: "\[18F\]Fluoroestradiol: An investigational positron emission tomography (PET) radiopharmaceutical for injection, intended for use as an in vivo diagnostic for imaging estrogen receptors in tumors Gadobenate dimeglumine: Gadolinium-based intravenous contrast agent used for the MRI portion of this study
Prognostic Risk Categories Determined Using Van Nuys Prognostic Index, the MSKCC Nomogram	NA AUC Lack of events

SECONDARY outcome

Timeframe: 12 months

Population: There was not enough amount of RNA starting material from the samples to perform the assay. No data was collected for this outcome since the research-based assay could not be performed due to insufficient RNA isolation.

To estimate the association of quantitative 18F-FES uptake (continuous SUVmax) with research-based Oncotype DX DCIS scores (0-100), scatter plots of continuous quantitative 18F-FES uptake (SUVmax) on the y-axis and research-based Oncotype DX DCIS scores (unitless) on the x-axis will be created to explore the distribution of the measurements. Pearson's or Spearman's rank correlation will be used to evaluate the association between quantitative 18F-FES uptake and research-based Oncotype DX DCIS score. The correlation coefficient (rho) and 95% confidence interval will be reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 months

This percentage will be calculated by dividing the number of patients with invasive breast cancer diagnosed at the time of surgical excision by the number of patients with percutaneous biopsy-proven DCIS in the study.

Outcome measures

Outcome measures
Measure	Research Arm n=12 Participants Directed breast PET/MRI with 18F-FES; 18F-FES uptake of the known malignancy to be measured on the PET/MRI examination (18F)FES: 18F-FES is an investigational new drug which will be used for this study. For complete information, please refer to the Investigator's Brochure: "\[18F\]Fluoroestradiol: An investigational positron emission tomography (PET) radiopharmaceutical for injection, intended for use as an in vivo diagnostic for imaging estrogen receptors in tumors Gadobenate dimeglumine: Gadolinium-based intravenous contrast agent used for the MRI portion of this study
Number of Participants With Invasive Cancer at Surgical Excision	2 Participants

SECONDARY outcome

Timeframe: 1 day

Mean serum estradiol levels will be reported to summarize the outcome measure.

Outcome measures

Outcome measures
Measure	Research Arm n=12 Participants Directed breast PET/MRI with 18F-FES; 18F-FES uptake of the known malignancy to be measured on the PET/MRI examination (18F)FES: 18F-FES is an investigational new drug which will be used for this study. For complete information, please refer to the Investigator's Brochure: "\[18F\]Fluoroestradiol: An investigational positron emission tomography (PET) radiopharmaceutical for injection, intended for use as an in vivo diagnostic for imaging estrogen receptors in tumors Gadobenate dimeglumine: Gadolinium-based intravenous contrast agent used for the MRI portion of this study
Serum Estradiol Levels	31.3 picograms per milliliter (pg/mL) Standard Deviation 46.0

SECONDARY outcome

Timeframe: 1 day

A correlation analysis of sex hormone binding globulin levels will be performed using Pearson's or Spearman's rank correlation. Scatter plots, correlation coefficients (rho) and 95% confidence intervals will be reported.

Outcome measures

Outcome measures
Measure	Research Arm n=12 Participants Directed breast PET/MRI with 18F-FES; 18F-FES uptake of the known malignancy to be measured on the PET/MRI examination (18F)FES: 18F-FES is an investigational new drug which will be used for this study. For complete information, please refer to the Investigator's Brochure: "\[18F\]Fluoroestradiol: An investigational positron emission tomography (PET) radiopharmaceutical for injection, intended for use as an in vivo diagnostic for imaging estrogen receptors in tumors Gadobenate dimeglumine: Gadolinium-based intravenous contrast agent used for the MRI portion of this study
Serum Sex Hormone Binding Globulin Levels	64.4 nanomoles per liter (nmol/L) Standard Deviation 43.0

Adverse Events

Research Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Research Arm n=12 participants at risk Directed breast PET/MRI with 18F-FES; 18F-FES uptake of the known malignancy to be measured on the PET/MRI examination (18F)FES: 18F-FES is an investigational new drug which will be used for this study. For complete information, please refer to the Investigator's Brochure: "\[18F\]Fluoroestradiol: An investigational positron emission tomography (PET) radiopharmaceutical for injection, intended for use as an in vivo diagnostic for imaging estrogen receptors in tumors Gadobenate dimeglumine: Gadolinium-based intravenous contrast agent used for the MRI portion of this study
Injury, poisoning and procedural complications IV site pain during injection	8.3% 1/12 • up to 24 hours

Additional Information

Amy Fowler, MD, PhD

UW School of Medicine and Public Health

Phone: 608-262-2122

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place