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Rapid Motion-Robust Quantitative DCE-MRI for the Diagnosis of Gynecologic Cancer
Trial Status: active
This phase I trial develops and tests the effect of a new rapid motion-robust quantitative dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in diagnosing gynecologic cancer. Currently, doctors rely on MRI to determine the stage and extent of gynecologic cancers, and to make decisions about how to treat these cancers. Traditional MRI produces detailed images that can show tumor size and location, but these images take a long time to process and may be blurred if the patient moves inside the scanner. DCE MRI is a new imaging technique that uses additional computer processing to collect information continuously during scanning, which produces clearer images in less time, and provides important information about tumor activity and aggressiveness. This trial aims to see whether a new type of DCE MRI produces better images that are less likely to be blurred by movement inside the scanner, and to see whether, by showing tumors that may have been missed by traditional MRI and providing additional information about the tumor, DCE MRI images can improve treatment decisions for women with gynecologic cancer.
Inclusion Criteria
HEALTHY VOLUNTEERS: Women aged 18 years or older
HEALTHY VOLUNTEERS: Willing and able to provide informed consent
PATIENTS: Women aged 18 years or older
PATIENTS: Gynecologic cancer undergoing standard of care pelvic MRI
PATIENTS: Willing and able to provide informed consent and adhere to the study visit schedule and plan as specified in this protocol
Exclusion Criteria
History of allergic reactions to gadolinium-based contrast agents (GBCAs)
Women of childbearing potential (WOCBP) must not be pregnant
Women must not be breastfeeding
Contraindications/risk factors to 3 Tesla (3T) MRI as per assessed by our departmental “Comprehensive MRI Screening Questionnaire” and “MRI Contrast Dye Questionnaire” (e.g. risk factors associated with magnetic field such as cardiac pacemakers, defibrillators or other devices as per standard institutional policy; and risk factors associated with GBCM such as diabetes, dialysis, breastfeeding)
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04893434.
I. Develop and implement a fast motion-resistant quantitative DCE-MRI technique using radial acquisition, compressed sensing, and pharmacokinetic modeling.
II. Evaluate the pilot cohort and image quality of the DCE-MRI technique in 10 patients with gynecologic malignancy using a single standard-of-care imaging session.
IIa. Assess motion robustness and parametric map interpretability;
IIb. Confirm clinical operability within routine workflow.
III. Use available volunteer and pilot data to support continued development of deep learning-based reconstruction algorithms, as feasible with existing resources.
OUTLINE:
AIM I: Healthy volunteers receive gadobutrol intravenously (IV) and undergo a single DCE-MRI to help develop new DCE-MRI technique.
AIM II: Patients receive gadobutrol IV and undergo DCE-MRI at baseline and at 2 weeks after completion of chemoradiation treatment per standard of care.
Trial PhasePhase I
Trial Typediagnostic
Lead OrganizationMemorial Sloan Kettering Cancer Center
