Novel Imaging Technique to Assess Gynecologic Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 1

Conditions: Gynecologic Cancer

Treatments: Drug: Gadobutrol; Diagnostic Test: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT04893434

21-038

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

DCE-MR images with Gadobutrol (GBCA)

Experimental group

Description:

10 volunteers will undergo a single DCE-MRI of the normal cervix to fine-tune parameters and test the performance of reconstruction and quantification algorithms. Goldenangled radial LAVA data will be continuously acquired for 5 minutes and the contrast agent will be injected intravenously after 1 minute (same contrast agent and injection rate. 60 gynecologic cancer patients will be enrolled (inclusion criterion: newly diagnosed gynecologic cancer scheduled for standard of care pelvic MRI for staging). Data from 30 of the patients will be used to assess repeatability; DCE-MRI will be acquired at baseline and 2 weeks (+/- 3 days) after completion of standard of care treatment. Data from the other 30 patients will be used to document treatment induced changes in DCE-MRI; patients in this group will undergo DCE-MRI at baseline and repeated after 2 weeks (+/- 3 days) of completion of chemoradiation treatment.

Treatment:

Diagnostic Test: MRI

Drug: Gadobutrol