Active — Not RecruitingPhase 1

Novel Imaging Technique to Assess Gynecologic Cancer

United States24 participantsStarted 2021-05-13

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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) 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)

What they're measuring

assess changes in Ktrans value

Timeframe: baseline

assess changes in Ktrans value

Timeframe: 48 hours

Trial details

NCT IDNCT04893434

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05