An interventional study of Hybrid breast FDG PET/MRI in Newly Diagnosed Breast Cancer, sponsored by Weill Medical College of Cornell University. Terminated at 1 site in United States. Open to female participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2023-02-22.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 14 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
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.
Diagnostic Test: Hybrid breast FDG PET/MRI
Hybrid breast FDG PET/MRI
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
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
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
Number of Interval Recurrences
Time frame: 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
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
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
| Milestone | Women With Newly Diagnosed Breast Cancer |
|---|---|
| Started | 14 |
| Completed | 14 |
| Not completed | 0 |
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.
| percentage of true negative | Women With Newly Diagnosed Breast Cancer |
|---|---|
| Specificity of MRI alone | 63.89 (59.1 to 68.9) |
| Specificity of PET-MRI | 83.33 (74.9 to 91.1) |
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.
| percentage | Women With Newly Diagnosed Breast Cancer |
|---|---|
| Sensitivity of MRI alone | 66.67 (39.6 to 94.4) |
| Sensitivity of PET-MRI (percent true positives exclusives of the index tumor) | 0 (0 to 0) |
| PPV of MRI alone | 23.53 (18.1 to 27.9) |
| PPV of PET-MRI(% probability of true positives exclusive of the index tumor) | 0 (0 to 0) |
| NPV of MRI alone | 92.00 (86.6 to 98.7) |
| NPV of PET-MRI | 83.33 (81.5 to 84.5) |
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.
| average signal to noise ratio | Women With Newly Diagnosed Breast Cancer |
|---|---|
| Dose Proportion of standard 10 mCi IV FDG dose: 1.01 | 1.799 |
| Dose Proportion of standard 10 mCi IV FDG dose: 1.007 | 4.427 |
| Dose Proportion of standard 10 mCi IV FDG dose: 0.802 | 9.333 |
| Dose Proportion of standard 10 mCi IV FDG dose: 0.805 | 2 |
| Dose Proportion of standard 10 mCi IV FDG dose: 0.6 | 6.25 |
| Dose Proportion of standard 10 mCi IV FDG dose: 0.631 | 4 |
| Dose Proportion of standard 10 mCi IV FDG dose: 0.505 | 5.222 |
| Dose Proportion of standard 10 mCi IV FDG dose: 0.491 | 13.3 |
| Dose Proportion of standard 10 mCi IV FDG dose: 0.58 | 11.333 |
| Dose Proportion of standard 10 mCi IV FDG dose: 0.65 | 6.778 |
| Dose Proportion of standard 10 mCi IV FDG dose: 0.593 | 4.6 |
| Dose Proportion of standard 10 mCi IV FDG dose: 0.4 | 3.2 |
| Dose Proportion of standard 10 mCi IV FDG dose: 0.401 | 11 |
| participants | Women With Newly Diagnosed Breast Cancer |
|---|---|
| Number of Interval Recurrences | 1 |
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.
| percentage | Women With Newly Diagnosed Breast Cancer |
|---|---|
| Sensitivity of MRI alone | 33.33 (-21.8 to 87.8) |
| Sensitivity of PET-MRI ( percent of true positive nodal disease in addition to MRI alone) | 0 (0 to 0) |
| Specificity of MRI alone | 76.92 (57.8 to 96.2) |
| Specificity of PET-MRI | 87.18 (78.8 to 95.2) |
| PPV of MRI alone | 10.00 (-21.8 to 87.8) |
| PPV of PET-MRI (% probability of true positives of nodal disease) | 0 (0 to 0) |
| NPV of MRI alone | 93.75 (87.2 to 98.8) |
| NPV of PET-MRI | 91.89 (91.5 to 92.5) |
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.
| scores on a scale | Women With Newly Diagnosed Breast Cancer |
|---|---|
| Perceived Patient Benefit of Undergoing a Simultaneous FDG PET/MRI Will be Summarized | 4.28 ± 0.49 |
Collected over 3 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Women With Newly Diagnosed Breast Cancer | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Categorical(Participants) | Women With Newly Diagnosed Breast Cancer |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 13 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Women With Newly Diagnosed Breast Cancer |
|---|---|
| Female | 14 |
| Male | 0 |
| Race and Ethnicity Not Collected(Participants) | Women With Newly Diagnosed Breast Cancer |
|---|
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Weill Medical College of Cornell University