Status:
RECRUITING
Novel Imaging Technique to Assess Gynecologic Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Gynecologic Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 informati...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
May 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04893434
Start Date
May 13 2021
End Date
May 1 2026
Last Update
March 5 2025
Active Locations (3)
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1
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
3
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, United States, 11553