Novel Imaging Technique to Assess Gynecologic Cancer

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04893434
• Other study ID #: 21-038
• Status: Recruiting
• Phase: Phase 1
• Start date: May 13, 2021
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Oguz Akin, MD
• Phone: 212-639-3458
• Email: akino[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

Drug:
• Gadobutrol
Each patient will undergo 3 Gadavist injections. 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. Each volunteer will undergo 1 and each patient 2 research Gadobutrol injections (the 3 injections mentioned in the protocol for patients is to account for the fact they will have had 1 injection as part of their standard of care, but the study only includes 2 research injections).

Diagnostic Test:
• MRI
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Bergen (All Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (All Protocol Activities)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess changes in Ktrans value	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	baseline
Primary	assess changes in Ktrans value	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	48 hours

External Links

•   Memorial Sloan Kettering Cancer Center