New imaging technique for assessing gynecologic cancer

Rapid Motion-Robust Quantitative DCE-MRI For The Assessment Of Gynecologic Cancer

This study is testing a new type of MRI that uses advanced technology to see if it can provide clearer images of gynecologic tumors in women with cancer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Memorial Sloan Kettering Cancer Center (Academic / other)
• Locations: 3 sites (Montvale, New Jersey and 2 other locations)
• Trial ID: NCT04893434 on ClinicalTrials.gov

What this trial studies

This study tests a novel dynamic contrast-enhanced MRI (DCE-MRI) to evaluate its effectiveness in providing clearer and more detailed images of gynecologic tumors compared to traditional MRI. The DCE-MRI technique utilizes advanced computer processing to capture continuous imaging data, which helps reduce motion blur and enhances the information available about tumor activity. The study will involve women aged 18 and older with gynecologic cancer who are scheduled for standard pelvic MRI prior to treatment. The contrast agent used in this study, gadobutrol, is FDA-approved and will be administered during the MRI scans.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 years or older with a diagnosis of gynecologic cancer who are scheduled for a standard pelvic MRI prior to treatment.

Not a fit: Patients who have a history of allergic reactions to gadolinium-based contrast agents or are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this imaging technique could lead to improved treatment decisions for women with gynecologic cancer by providing more accurate tumor assessments.

How similar studies have performed: Other studies have shown promise with advanced imaging techniques, suggesting potential for success with this novel approach.

Eligibility 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)

Where this trial is running

Montvale, New Jersey and 2 other locations

• Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
• Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale, New York, United States (Recruiting)

Study contacts

• Principal investigator: Oguz Akin, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Oguz Akin, MD

Conditions Gynecologic Cancer; DCE-MRI; Gadobutrol; 21-038