Novel Imaging Technique to Assess Gynecologic Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Gynecologic Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan Kettering Bergen (All Protocol Activities), Montvale, New Jersey, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gadobutrol

Drug

All DCE imaging will be performed after the intravenous injection of the GBCA Gadobutrol (Gadavist, Bayer Healthcare) at 0.1 mL/kg body weight (0.1 mmol/kg), administered as a bolus at a flow rate of approximately 2 mL/s.

MRI

Diagnostic Test

All subjects will be imaged on the same 3T MRI scanner (GE Healthcare, USA) at MSK for all examinations. For SA1, subjects will undergo a single research DCE-MRI exam. Patients in SA2 will undergo a standard of care pelvic MRI at baseline (which includes DCE-standard) in accordance with standard clinical operating procedures at MSK.

Primary outcomes

assess changes in Ktrans value

Time frame: baseline

Each MRI sequence will have a DCE-MRI quantitative metric Ktrans value for each of 2 independent readers. The Ktrans value will be generated from the ROIs placed independently by each radiologists using dedicated software
assess changes in Ktrans value

Time frame: 48 hours

Each MRI sequence will have a DCE-MRI quantitative metric Ktrans value for each of 2 independent readers. The Ktrans value will be generated from the ROIs placed independently by each radiologists using dedicated software

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2027
Study completion: 2027
First posted: May 19, 2021
Registry last updated: Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Active, Not Recruiting