Gynecologic Cancer
Conditions
Keywords
DCE-MRI, Gadobutrol, 21-038
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.
Interventions
DRUGGadobutrol
All DCE imaging will be performed after the intravenous injection of the GBCA Gadobutrol (Gadavist, Bayer Healthcare) at 0.1 mL/kg body weight (0.1 mmol/kg), administered as a bolus at a flow rate of approximately 2 mL/s.
DIAGNOSTIC_TESTMRI
All subjects will be imaged on the same 3T MRI scanner (GE Healthcare, USA) at MSK for all examinations. For SA1, subjects will undergo a single research DCE-MRI exam. Patients in SA2 will undergo a standard of care pelvic MRI at baseline (which includes DCE-standard) in accordance with standard clinical operating procedures at MSK.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This will be a prospective, single center non-randomized study. This study has two parts: Part 1 (volunteers) and Part 2 (women with gynecologic cancer).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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 * Willing and able to provide informed consent and adhere to the study visit schedule and plan as specified in this protocol.
Exclusion criteria
Healthy volunteers (SA1) and patients (SA2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assess changes in Ktrans value | baseline | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOROguz Akin, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed