Clinical trial · Interventional
Dedicated Breast PET/MRI in Evaluation of Extent of Disease in Women With Newly Diagnosed Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Temporarily paused per study team for interim data review.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Newly Diagnosed Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hybrid breast FDG PET/MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Women with newly diagnosed breast cancer
- description
- 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.
- interventionNames
- Diagnostic Test: Hybrid breast FDG PET/MRI
Primary outcomes (1)
- measure
- 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
- timeFrame
- 24 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available