Trial Outcomes & Findings for Dedicated Breast PET/MRI in Evaluation of Extent of Disease in Women With Newly Diagnosed Breast Cancer (NCT NCT03510988)

NCT ID: NCT03510988

Last Updated: 2023-02-22

Results Overview

Blinded breast imaging readers were provided at random a reading list of anonymized studies of breast PET/MRIs and MRI alone from the study cohort and asked to assess lesions suspicious for malignancy. Specificity of all lesions on PET-MRI compared to MRI alone is assessed by the percentage of true negatives out of all benign/non-malignant lesions.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2023-02-22

Participant Flow

Participant milestones

Measure	Women With Newly Diagnosed Breast Cancer Women with newly diagnosed breast cancer recruited for hybrid dedicated breast PET/MRI for extent of disease staging prior to management in lieu of breast MRI alone. IV FDG and Gadolinium was injected once prior to the study as per protocol and weight. In each second consecutively recruited patient FDG dosage was decreased by 20% up to 40% of weight-based dosage to ascertain feasibility of imaging at lower FDG dosages. IV Gadolinium was injected once with weight dependent dosages as per clinical standard of care.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Women With Newly Diagnosed Breast Cancer n=14 Participants Women with newly diagnosed breast cancer recruited for hybrid dedicated breast PET/MRI for extent of disease staging prior to management in lieu of breast MRI alone. IV FDG and Gadolinium was injected once prior to the study as per protocol and weight. In each second consecutively recruited patient FDG dosage was decreased by 20% up to 40% of weight-based dosage to ascertain feasibility of imaging at lower FDG dosages. IV Gadolinium was injected once with weight dependent dosages as per clinical standard of care
Age, Categorical <=18 years	0 Participants n=14 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=14 Participants
Age, Categorical >=65 years	1 Participants n=14 Participants
Sex: Female, Male Female	14 Participants n=14 Participants
Sex: Female, Male Male	0 Participants n=14 Participants

PRIMARY outcome

Timeframe: 24 months

Blinded breast imaging readers were provided at random a reading list of anonymized studies of breast PET/MRIs and MRI alone from the study cohort and asked to assess lesions suspicious for malignancy. Specificity of all lesions on PET-MRI compared to MRI alone is assessed by the percentage of true negatives out of all benign/non-malignant lesions.

Outcome measures

Measure	Women With Newly Diagnosed Breast Cancer n=14 Participants Women with newly diagnosed breast cancer recruited for hybrid dedicated breast PET/MRI for extent of disease staging prior to management in lieu of breast MRI alone. IV FDG and Gadolinium was injected once prior to the study as per protocol and weight. In each second consecutively recruited patient FDG dosage was decreased by 20% up to 40% of weight-based dosage to ascertain feasibility of imaging at lower FDG dosages. IV Gadolinium was injected once with weight dependent dosages as per clinical standard of care
Specificity of the PET-MRI Compared to MRI Alone as Assessed by the Percentage of True Negatives Out of All Benign/Non-malignant Lesions Breast Cancer Specificity of MRI alone	63.89 percentage of true negative Interval 59.1 to 68.9
Specificity of the PET-MRI Compared to MRI Alone as Assessed by the Percentage of True Negatives Out of All Benign/Non-malignant Lesions Breast Cancer Specificity of PET-MRI	83.33 percentage of true negative Interval 74.9 to 91.1

SECONDARY outcome

Timeframe: 24 months post-intervention

Blinded radiologists evaluated a list of anonymized studies of breast MRI alone and after washout period the same MRI with ovelayed PET from a hybrid PETMRI study cohort and asked to assess lesions suspicious for malignancy in addition to known index tumor. Measures of diagnostic accuracy( sensitivity, specificity, PPV and NPV) for any and all additional lesions exclusive of the known index tumor detected by readers were calculated for MRI alone and for PET/MRI. Due to washout period readers assessed the imaging of hybrid PET/MRI in complement, as such readers may assess previously questioned MRI findings as benign in the absence of FDG uptake. Sensitivity is the % of true positive & specificity is the % of true negative. PPV is the probability that if imaging was assessed as suspicious on biopsy was malignant. NPV is the % likelihood that if imaging was assessed as negative there was no additional malignancy on surgical excision.

Outcome measures

Measure	Women With Newly Diagnosed Breast Cancer n=14 Participants Women with newly diagnosed breast cancer recruited for hybrid dedicated breast PET/MRI for extent of disease staging prior to management in lieu of breast MRI alone. IV FDG and Gadolinium was injected once prior to the study as per protocol and weight. In each second consecutively recruited patient FDG dosage was decreased by 20% up to 40% of weight-based dosage to ascertain feasibility of imaging at lower FDG dosages. IV Gadolinium was injected once with weight dependent dosages as per clinical standard of care
Sensitivity, PPV (Positive Predictive Value), and NPV (Negative Predictive Value) for the Diagnosis Based on the Entire PET/MRI and MRI Alone Will be Calculated and Reported Along With the Corresponding Two-sided 90% Confidence Intervals. Sensitivity of MRI alone	66.67 percentage Interval 39.6 to 94.4
Sensitivity, PPV (Positive Predictive Value), and NPV (Negative Predictive Value) for the Diagnosis Based on the Entire PET/MRI and MRI Alone Will be Calculated and Reported Along With the Corresponding Two-sided 90% Confidence Intervals. Sensitivity of PET-MRI (percent true positives exclusives of the index tumor)	0 percentage Interval 0.0 to 0.0
Sensitivity, PPV (Positive Predictive Value), and NPV (Negative Predictive Value) for the Diagnosis Based on the Entire PET/MRI and MRI Alone Will be Calculated and Reported Along With the Corresponding Two-sided 90% Confidence Intervals. PPV of MRI alone	23.53 percentage Interval 18.1 to 27.9
Sensitivity, PPV (Positive Predictive Value), and NPV (Negative Predictive Value) for the Diagnosis Based on the Entire PET/MRI and MRI Alone Will be Calculated and Reported Along With the Corresponding Two-sided 90% Confidence Intervals. PPV of PET-MRI(% probability of true positives exclusive of the index tumor)	0 percentage Interval 0.0 to 0.0
Sensitivity, PPV (Positive Predictive Value), and NPV (Negative Predictive Value) for the Diagnosis Based on the Entire PET/MRI and MRI Alone Will be Calculated and Reported Along With the Corresponding Two-sided 90% Confidence Intervals. NPV of MRI alone	92.00 percentage Interval 86.6 to 98.7
Sensitivity, PPV (Positive Predictive Value), and NPV (Negative Predictive Value) for the Diagnosis Based on the Entire PET/MRI and MRI Alone Will be Calculated and Reported Along With the Corresponding Two-sided 90% Confidence Intervals. NPV of PET-MRI	83.33 percentage Interval 81.5 to 84.5

SECONDARY outcome

Timeframe: 24 months post-intervention

Population: The average signal to noise ratio was unable to be measured for one subject.

PET imaging was assessed for signal-to-noise ratio of maximum standardized uptake value (SUVmax) over the breast background SUVmean. This is compiled below for each administered dose of FDG. Each subject received one FDG and one gadolinium dose IV injection.

Outcome measures

Measure	Women With Newly Diagnosed Breast Cancer n=13 Participants Women with newly diagnosed breast cancer recruited for hybrid dedicated breast PET/MRI for extent of disease staging prior to management in lieu of breast MRI alone. IV FDG and Gadolinium was injected once prior to the study as per protocol and weight. In each second consecutively recruited patient FDG dosage was decreased by 20% up to 40% of weight-based dosage to ascertain feasibility of imaging at lower FDG dosages. IV Gadolinium was injected once with weight dependent dosages as per clinical standard of care
Average Signal to Noise Ratios (SNR) vs. IV FDG Dosages Will be Summarized in Plot Format. Dose Proportion of standard 10 mCi IV FDG dose: 1.01	1.799 average signal to noise ratio
Average Signal to Noise Ratios (SNR) vs. IV FDG Dosages Will be Summarized in Plot Format. Dose Proportion of standard 10 mCi IV FDG dose: 1.007	4.427 average signal to noise ratio
Average Signal to Noise Ratios (SNR) vs. IV FDG Dosages Will be Summarized in Plot Format. Dose Proportion of standard 10 mCi IV FDG dose: 0.802	9.333 average signal to noise ratio
Average Signal to Noise Ratios (SNR) vs. IV FDG Dosages Will be Summarized in Plot Format. Dose Proportion of standard 10 mCi IV FDG dose: 0.805	2 average signal to noise ratio
Average Signal to Noise Ratios (SNR) vs. IV FDG Dosages Will be Summarized in Plot Format. Dose Proportion of standard 10 mCi IV FDG dose: 0.6	6.25 average signal to noise ratio
Average Signal to Noise Ratios (SNR) vs. IV FDG Dosages Will be Summarized in Plot Format. Dose Proportion of standard 10 mCi IV FDG dose: 0.631	4 average signal to noise ratio
Average Signal to Noise Ratios (SNR) vs. IV FDG Dosages Will be Summarized in Plot Format. Dose Proportion of standard 10 mCi IV FDG dose: 0.505	5.222 average signal to noise ratio
Average Signal to Noise Ratios (SNR) vs. IV FDG Dosages Will be Summarized in Plot Format. Dose Proportion of standard 10 mCi IV FDG dose: 0.491	13.3 average signal to noise ratio
Average Signal to Noise Ratios (SNR) vs. IV FDG Dosages Will be Summarized in Plot Format. Dose Proportion of standard 10 mCi IV FDG dose: 0.58	11.333 average signal to noise ratio
Average Signal to Noise Ratios (SNR) vs. IV FDG Dosages Will be Summarized in Plot Format. Dose Proportion of standard 10 mCi IV FDG dose: 0.65	6.778 average signal to noise ratio
Average Signal to Noise Ratios (SNR) vs. IV FDG Dosages Will be Summarized in Plot Format. Dose Proportion of standard 10 mCi IV FDG dose: 0.593	4.6 average signal to noise ratio
Average Signal to Noise Ratios (SNR) vs. IV FDG Dosages Will be Summarized in Plot Format. Dose Proportion of standard 10 mCi IV FDG dose: 0.4	3.2 average signal to noise ratio
Average Signal to Noise Ratios (SNR) vs. IV FDG Dosages Will be Summarized in Plot Format. Dose Proportion of standard 10 mCi IV FDG dose: 0.401	11 average signal to noise ratio

SECONDARY outcome

Timeframe: 24 months post-intervention

Outcome measures

Measure

Women With Newly Diagnosed Breast Cancer n=14 Participants Women with newly diagnosed breast cancer recruited for hybrid dedicated breast PET/MRI for extent of disease staging prior to management in lieu of breast MRI alone. IV FDG and Gadolinium was injected once prior to the study as per protocol and weight. In each second consecutively recruited patient FDG dosage was decreased by 20% up to 40% of weight-based dosage to ascertain feasibility of imaging at lower FDG dosages. IV Gadolinium was injected once with weight dependent dosages as per clinical standard of care

Number of Interval Recurrences

1 participants

SECONDARY outcome

Timeframe: 24 months post-intervention

Blinded breast imaging readers were provided at random a reading list of anonymized studies of breast PET/MRIs and MRI alone from the study cohort and asked to assess nodal disease as a whole (present/absent). Sensitivity, specificity, PPV (positive predictive value), and NPV (negative predictive value) of nodal metastasis (presence or absence) of hybrid breast FDG PET/MRI vs breast MRI alone were compared. Due to washout period readers assessed the imaging of hybrid PET/MRI in complement, as such readers may assess previously questioned MRI findings as benign in the absence of FDG uptake.

Outcome measures

Measure	Women With Newly Diagnosed Breast Cancer n=14 Participants Women with newly diagnosed breast cancer recruited for hybrid dedicated breast PET/MRI for extent of disease staging prior to management in lieu of breast MRI alone. IV FDG and Gadolinium was injected once prior to the study as per protocol and weight. In each second consecutively recruited patient FDG dosage was decreased by 20% up to 40% of weight-based dosage to ascertain feasibility of imaging at lower FDG dosages. IV Gadolinium was injected once with weight dependent dosages as per clinical standard of care
Sensitivity in Detection of Axillary and Internal Mammary Lymph Node Metastasis Between the Hybrid Breast FDG PET/MRI vs Breast MRI Alone Will be Summarized Sensitivity of MRI alone	33.33 percentage Interval -21.8 to 87.8
Sensitivity in Detection of Axillary and Internal Mammary Lymph Node Metastasis Between the Hybrid Breast FDG PET/MRI vs Breast MRI Alone Will be Summarized Sensitivity of PET-MRI ( percent of true positive nodal disease in addition to MRI alone)	0 percentage Interval 0.0 to 0.0
Sensitivity in Detection of Axillary and Internal Mammary Lymph Node Metastasis Between the Hybrid Breast FDG PET/MRI vs Breast MRI Alone Will be Summarized Specificity of MRI alone	76.92 percentage Interval 57.8 to 96.2
Sensitivity in Detection of Axillary and Internal Mammary Lymph Node Metastasis Between the Hybrid Breast FDG PET/MRI vs Breast MRI Alone Will be Summarized Specificity of PET-MRI	87.18 percentage Interval 78.8 to 95.2
Sensitivity in Detection of Axillary and Internal Mammary Lymph Node Metastasis Between the Hybrid Breast FDG PET/MRI vs Breast MRI Alone Will be Summarized PPV of MRI alone	10.00 percentage Interval -21.8 to 87.8
Sensitivity in Detection of Axillary and Internal Mammary Lymph Node Metastasis Between the Hybrid Breast FDG PET/MRI vs Breast MRI Alone Will be Summarized PPV of PET-MRI (% probability of true positives of nodal disease)	0 percentage Interval 0.0 to 0.0
Sensitivity in Detection of Axillary and Internal Mammary Lymph Node Metastasis Between the Hybrid Breast FDG PET/MRI vs Breast MRI Alone Will be Summarized NPV of MRI alone	93.75 percentage Interval 87.2 to 98.8
Sensitivity in Detection of Axillary and Internal Mammary Lymph Node Metastasis Between the Hybrid Breast FDG PET/MRI vs Breast MRI Alone Will be Summarized NPV of PET-MRI	91.89 percentage Interval 91.5 to 92.5

SECONDARY outcome

Timeframe: 24 months post-intervention

Population: Seven out fourteen subjects elected to complete the questionnaire.

Subjects will be asked to fill out a questionnaire at the conclusion of their breast PET/MRI exam assessing on a scale of 1 - 5 how important it was for them to save time to do the PET/MRI simultaneously knowing that they may have a negative PET/MRI for extent of disease (no additional sites of disease aside from index cancer), how valuable it is for them to potentially avoid unnecessary biopsies if the study hypothesis is correct, and how important it is to them to decrease delay to surgery.

Outcome measures

Measure

Women With Newly Diagnosed Breast Cancer n=7 Participants Women with newly diagnosed breast cancer recruited for hybrid dedicated breast PET/MRI for extent of disease staging prior to management in lieu of breast MRI alone. IV FDG and Gadolinium was injected once prior to the study as per protocol and weight. In each second consecutively recruited patient FDG dosage was decreased by 20% up to 40% of weight-based dosage to ascertain feasibility of imaging at lower FDG dosages. IV Gadolinium was injected once with weight dependent dosages as per clinical standard of care

Perceived Patient Benefit of Undergoing a Simultaneous FDG PET/MRI Will be Summarized

4.28 scores on a scale Standard Deviation 0.49

Adverse Events

Women With Newly Diagnosed Breast Cancer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Katerina Dodelzon, MD

Weill Cornell Medicine

Phone: 646 962 9650

Email: kad9090@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place