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Enhanced MRI for Cervical Cancer

Phase 1
Recruiting
Led By Oguz Akin, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients (for SA2): 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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights

Study Summary

This trial will test whether DCE MRI can provide better images of cervical cancer than traditional MRI, which may help doctors make better decisions about treating women who have cervical cancer.

Who is the study for?
This trial is for women aged 18 or older with gynecologic cancer who are about to receive standard pelvic MRI before treatment. Participants must be planning chemoradiation (for SA2b only), able to consent, and follow the study's schedule.Check my eligibility
What is being tested?
The study tests a new DCE MRI technique using gadobutrol contrast against traditional MRI. It aims to produce clearer, more detailed images quickly, potentially improving tumor assessment and treatment decisions in gynecologic cancers.See study design
What are the potential side effects?
Gadobutrol may cause side effects like headache, nausea, dizziness, or a reaction at the injection site. Rarely it can lead to allergic reactions or changes in taste.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman over 18 with gynecologic cancer, planning to follow the study's treatment and visit schedule.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
assess changes in Ktrans value

Trial Design

1Treatment groups
Experimental Treatment
Group I: DCE-MR images with Gadobutrol (GBCA)Experimental Treatment2 Interventions
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 repeated 48 hours (+/- 24 h) later (no therapy between the 2 scans). 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
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~1370
Gadobutrol
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,828 Total Patients Enrolled
5 Trials studying Gynecologic Cancers
573 Patients Enrolled for Gynecologic Cancers
Oguz Akin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
424 Total Patients Enrolled
Hebert Alberto Vargas, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

MRI Clinical Trial Eligibility Overview. Trial Name: NCT04893434 — Phase 1
Gynecologic Cancers Research Study Groups: DCE-MR images with Gadobutrol (GBCA)
Gynecologic Cancers Clinical Trial 2023: MRI Highlights & Side Effects. Trial Name: NCT04893434 — Phase 1
MRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT04893434 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical experiment still accept participants?

"Clinicaltrials.gov confirms that this ongoing study is actively searching for participants since its initial posting on May 13th 2021 and most recent update on November 2nd 2022."

Answered by AI

Have any earlier experiments utilized Gadobutrol?

"As of now, 7 clinical experiments are taking place to analyze Gadobutrol with none in Phase 3. Most sites are situated within Worcester, Massachusetts although 40 other places have studies for Gadobutrol underway as well."

Answered by AI

Has the FDA approved Gadobutrol for use in patients?

"Due to limited clinical data, Gadobutrol's safety is estimated at a score of 1."

Answered by AI

What is the capacity of participants in this study?

"Affirmative. Clinicaltrials.gov verifies that this research endeavor, which was first published on May 13th 2021, is actively enrolling patients. Approximately 70 individuals are being sought from 3 different centres of care."

Answered by AI

In what particular circumstances is Gadobutrol typically administered?

"Gadobutrol is the typical prescribed treatment for individuals with supravalvular aortic stenosis. This drug may also be used to help with magnetic resonance angiography, certain breast diseases and renal artery stenosis."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Novel Imaging Technique to Assess Gynecologic Cancer
2021. "Novel Imaging Technique to Assess Gynecologic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04893434.
~18 spots leftby May 2025
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