Newly Diagnosed Breast Cancer
Conditions
Brief summary
This is a single institution study enrolling women over age 25 with newly diagnosed breast cancer and for whom a breast MR has been ordered as standard of care. Subjects will undergo a hybrid dedicated Breast PET/MRI in lieu of a breast MRI alone, for evaluation of extent of disease prior to surgical and oncologic management. The study will investigate any incremental added benefit to breast MRI specificity by the addition of concurrent hybrid breast PET.
Detailed description
The study hypothesis is that the combination of Breast PET/MRI, will improve specificity and decrease the number of false positive breast biopsies recommended based on breast MRI findings.
Interventions
DIAGNOSTIC_TESTHybrid breast FDG PET/MRI
Hybrid breast FDG PET/MRI
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women over age of 25 with newly diagnosed breast cancer and for whom a breast MR has been ordered as standard of care
Exclusion criteria
* Male subjects * Women younger than 25 * Pregnant subjects * Unable or unwilling to undergo MRI * Previous adverse reaction to 18F-FDG * Unwilling to undergo biopsy of MRI positive lesions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Average Signal to Noise Ratios (SNR) vs. IV FDG Dosages Will be Summarized in Plot Format. | 24 months post-intervention | 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. |
| Number of Interval Recurrences | 24 months post-intervention | — |
| 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 | 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. |
| Perceived Patient Benefit of Undergoing a Simultaneous FDG PET/MRI Will be Summarized | 24 months post-intervention | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Women With Newly Diagnosed Breast Cancer | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 1 Participants | — |
| Age, Categorical Between 18 and 65 years | 13 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 14 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
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
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.
Time frame: 24 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
Secondary
Average Signal to Noise Ratios (SNR) vs. IV FDG Dosages Will be Summarized in Plot Format.
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.
Time frame: 24 months post-intervention
Population: The average signal to noise ratio was unable to be measured for one subject.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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
Number of Interval Recurrences
Time frame: 24 months post-intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Women With Newly Diagnosed Breast Cancer | Number of Interval Recurrences | 1 participants |
Secondary
Perceived Patient Benefit of Undergoing a Simultaneous FDG PET/MRI Will be Summarized
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.
Time frame: 24 months post-intervention
Population: Seven out fourteen subjects elected to complete the questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women With Newly Diagnosed Breast Cancer | Perceived Patient Benefit of Undergoing a Simultaneous FDG PET/MRI Will be Summarized | 4.28 scores on a scale | Standard Deviation 0.49 |
Secondary
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
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.
Time frame: 24 months post-intervention
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
Secondary
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.
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.
Time frame: 24 months post-intervention
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |
| Women With Newly Diagnosed Breast Cancer | 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 |