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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 prior to treatment
PATIENTS: Planned treatment with chemoradiation (for specific aim 2b [SA2b] only)
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)
Additional locations may be listed on ClinicalTrials.gov for NCT04893434.
I. Develop and implement a new fast motion-resistant quantitative DCE-MRI technique that compared to the existing standard offers increased speed and resistance to motion; dynamic T1 mapping; and personalized and automated pharmacokinetic analysis.
Ia. Integration of new temporal reconstruction, dynamic T1 mapping and personalized arterial input function (AIF) estimation.
Ib. Automation of image analysis to extract parametric maps.
II. Evaluate the repeatability, reproducibility of the new DCE-MRI technique (“DCE-new”) and compare DCE-new to standard of care DCE-MRI (“DCE-standard”) in patients with gynecologic cancer, using the DCE-MRI derived metric K^trans assessed from two independent readers as the imaging endpoint.
IIa. Repeatability and reproducibility study using two DCE-new acquisitions per patient.
IIb. Treatment induced changes study using baseline and post chemoradiation DCE-new to assess changes in K^trans value before and after treatment.
IIIc. Comparison study: descriptive comparison of DCE-new technique to DCE-standard.
III. Develop and evaluate fast image reconstruction algorithms based on deep learning.
IIIa. Train a convolutional neural network using datasets and reconstruction results from Aim 2 to increase reconstruction speed to the order of seconds.
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, per standard of care and at 2 weeks after completion of standard of care chemoradiation treatment.
Trial PhasePhase I
Trial Typediagnostic
Lead OrganizationMemorial Sloan Kettering Cancer Center
