Novel Imaging Technique to Assess Gynecologic Cancer

NCT04893434 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 21-038
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

Gynecologic Cancer

Keywords

DCE-MRI; Gadobutrol; 21-038

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

DCE-MR images with Gadobutrol (GBCA)

EXPERIMENTAL

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. 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.

Drug: Gadobutrol; Diagnostic Test: MRI

Interventions

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.

DCE-MR images with Gadobutrol (GBCA)

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.

DCE-MR images with Gadobutrol (GBCA)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gynecologic Cancer
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (3)

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

gadobutrol

Study Officials

• Oguz Akin, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a prospective, single center non-randomized study. This study has two parts: Part 1 (volunteers) and Part 2 (women with gynecologic cancer).

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 19, 2021
• Study Start: May 13, 2021
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (3)