Novel Imaging Technique to Assess Gynecologic Cancer
- Registration Number
- NCT04893434
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
This study will test a new type of DCE (dynamic contrast-enhanced) MRI (magnetic resonance imaging) to see whether, compared with traditional MRI, it produces better images that provide more information about tumors, which may help doctors make better decisions about treating women who have gynecologic cancer.
MRI is commonly used to detect and evaluate many types of cancer, but its slow processing speed and the risk that images will be blurred if the patient moves inside the scanner can limit its use in clinical practice. DCE MRI is a new imaging technique that uses additional computer processing to collect information continuously during scanning, which produces more detailed images faster than traditional MRI, which reduces the risk of movement-related blurring and provides important information about tumor activity.
The DCE MRI scan in this study will be done in a standard MRI scanner, using a contrast agent (gadobutrol; Gadavist®) that has been approved by the FDA.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 70
Healthy volunteers (for SA1) will be entered into the study if they meet the following criteria:
- Women aged 18 years or older.
- Willing and able to provide informed consent
Patients (for SA2) will be entered into the study if they meet the following criteria:
- Women aged 18 years or older.
- Gynecologic cancer undergoing standard of care pelvic MRI prior to treatment
- Planned treatment with chemoradiation (for SA2b only)
- Willing and able to provide informed consent and adhere to the study visit schedule and plan as specified in this protocol.
Healthy volunteers (SA1) and patients (SA2) 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 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DCE-MR images with Gadobutrol (GBCA) Gadobutrol 10 volunteers will undergo a single DCE-MRI of the normal cervix to fine-tune parameters and test the performance of reconstruction and quantification algorithms. Goldenangled radial LAVA data will be continuously acquired for 5 minutes and the contrast agent will be injected intravenously after 1 minute (same contrast agent and injection rate. 60 gynecologic cancer patients will be enrolled (inclusion criterion: newly diagnosed gynecologic cancer scheduled for standard of care pelvic MRI for staging). Data from 30 of the patients will be used to assess repeatability; DCE-MRI will be acquired at baseline and 2 weeks (+/- 3 days) after completion of standard of care treatment. Data from the other 30 patients will be used to document treatment induced changes in DCE-MRI; patients in this group will undergo DCE-MRI at baseline and repeated after 2 weeks (+/- 3 days) of completion of chemoradiation treatment. DCE-MR images with Gadobutrol (GBCA) MRI 10 volunteers will undergo a single DCE-MRI of the normal cervix to fine-tune parameters and test the performance of reconstruction and quantification algorithms. Goldenangled radial LAVA data will be continuously acquired for 5 minutes and the contrast agent will be injected intravenously after 1 minute (same contrast agent and injection rate. 60 gynecologic cancer patients will be enrolled (inclusion criterion: newly diagnosed gynecologic cancer scheduled for standard of care pelvic MRI for staging). Data from 30 of the patients will be used to assess repeatability; DCE-MRI will be acquired at baseline and 2 weeks (+/- 3 days) after completion of standard of care treatment. Data from the other 30 patients will be used to document treatment induced changes in DCE-MRI; patients in this group will undergo DCE-MRI at baseline and repeated after 2 weeks (+/- 3 days) of completion of chemoradiation treatment.
- Primary Outcome Measures
Name Time Method assess changes in Ktrans value 48 hours Each MRI sequence will have a DCE-MRI quantitative metric Ktrans value for each of 2 independent readers. The Ktrans value will be generated from the ROIs placed independently by each radiologists using dedicated software
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Memorial Sloan Kettering Bergen (All Protocol Activities)
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
🇺🇸Uniondale, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States