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Novel Imaging Technique to Assess Gynecologic Cancer

RECRUITINGPhase 1Sponsored by Memorial Sloan Kettering Cancer Center
Actively Recruiting
PhasePhase 1
SponsorMemorial Sloan Kettering Cancer Center
Started2021-05-13
Est. completion2027-05
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations3 sites

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.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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)

Conditions2

CancerGynecologic Cancer

Locations3 sites

New Jersey

1 site
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Oguz Akin, MD212-639-3458

New York

2 sites
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Oguz Akin, MD212-639-3458
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553
Oguz Akin, MD212-639-3458

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