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NCT04893434 | RECRUITING | Gynecologic Cancer

Novel Imaging Technique to Assess Gynecologic Cancer
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.

Condition or disease

Gynecologic Cancer

Intervention/treatment

Gadobutrol

MRI

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 70 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Rapid Motion-Robust Quantitative DCE-MRI For The Assessment Of Gynecologic Cancer
Actual Study Start Date : 2021-05-13
Estimated Primary Completion Date : 2026-05
Estimated Study Completion Date : 2026-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
Criteria
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
      • * 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 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)
Novel Imaging Technique to Assess Gynecologic Cancer

Location Details

NCT04893434

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How to Participate

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Locations

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, United States, 11553