- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03510988
Dedicated Breast PET/MRI in Evaluation of Extent of Disease in Women With Newly Diagnosed Breast Cancer
January 27, 2023 updated by: Weill Medical College of Cornell University
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Weill Cornell Medical College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Hybrid breast FDG PET/MRI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 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.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 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.
|
24 months post-intervention
|
Average Signal to Noise Ratios (SNR) vs. IV FDG Dosages Will be Summarized in Plot Format.
Time Frame: 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.
|
24 months post-intervention
|
Number of Interval Recurrences
Time Frame: 24 months post-intervention
|
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
Time Frame: 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.
|
24 months post-intervention
|
Perceived Patient Benefit of Undergoing a Simultaneous FDG PET/MRI Will be Summarized
Time Frame: 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.
|
24 months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Katerina Dodelzon, MD, Weill Medical College of Cornell University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2018
Primary Completion (Actual)
March 4, 2020
Study Completion (Actual)
March 4, 2022
Study Registration Dates
First Submitted
April 5, 2018
First Submitted That Met QC Criteria
April 17, 2018
First Posted (Actual)
April 27, 2018
Study Record Updates
Last Update Posted (Estimate)
February 22, 2023
Last Update Submitted That Met QC Criteria
January 27, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1705018188
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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