Newly Diagnosed Breast CancerNCT03510988
Dedicated Breast PET/MRI in Evaluation of Extent of Disease in Women With Newly Diagnosed Breast Cancer
A study testing Hybrid breast FDG PET/MRI in people with Newly Diagnosed Breast Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Newly Diagnosed Breast Cancer
- What is being tested?
- Hybrid breast FDG PET/MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2018to 4 Mar 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women over age of 25 with newly diagnosed breast cancer and for whom a breast MR has been ordered as standard of care
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
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.
Read the 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.
- Conditions
- Newly Diagnosed Breast Cancer
- Being tested
- Hybrid breast FDG PET/MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid breast FDG PET/MRIDiagnostic test
Hybrid breast FDG PET/MRI
| Study group | Role | What they receive |
|---|---|---|
| Women with newly diagnosed breast cancer | Experimental | 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. Receives: Diagnostic Test: Hybrid breast FDG PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 24 months post-intervention
Number of Interval Recurrences
Measured: 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.
Measured: 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.
Measured: 24 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start15 Mar 2018
- Primary completion4 Mar 2020
- Study completion4 Mar 2022
Why it stopped: Temporarily paused per study team for interim data review.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Newly Diagnosed Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katerina Dodelzon, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510988
- Sponsor's protocol ID
- 1705018188
- Status last verified
- Jan 2023
- First submitted
- 5 Apr 2018
- Last updated
- 22 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes