Enhanced MRI for Cervical Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Oguz Akin, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Allergy to gadolinium, Pregnancy, Breastfeeding, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it is important to discuss your medications with the study team to ensure they do not interfere with the MRI or contrast agent used in the study.

How does the Enhanced MRI treatment for cervical cancer differ from other treatments?

Enhanced MRI for cervical cancer is unique because it uses high-resolution imaging to guide brachytherapy (a type of internal radiation therapy), allowing for more precise targeting of the cancerous tissue. This approach can improve the accuracy of treatment planning and potentially lead to better outcomes compared to traditional methods that do not use MRI guidance. ^{1 2 3 4 5}

Research Team

Oguz Akin, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I am a woman over 18 with gynecologic cancer, planning to follow the study's treatment and visit schedule.

I am a healthy woman, 18 or older, and can give informed consent.

Exclusion Criteria

Women must not be breastfeeding

History of allergic reactions to gadolinium-based contrast agents (GBCAs)

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 Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline DCE-MRI

Participants undergo a baseline DCE-MRI scan to fine-tune parameters and test performance of reconstruction and quantification algorithms

1 day

1 visit (in-person)

Post-treatment DCE-MRI

Participants undergo a DCE-MRI scan 2 weeks after completion of standard of care treatment to assess repeatability and treatment-induced changes

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Gadobutrol (Contrast Agent)

Trial Overview 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.

Participant Groups

Group I: DCE-MR images with Gadobutrol (GBCA) Experimental Treatment 2 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 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

Findings from Research

The standard treatment for locally advanced cervical cancer involves a combination of platinum-based chemotherapy, external beam radiotherapy (EBRT), and brachytherapy (BT), with MRI being the most effective imaging method for staging and evaluating treatment response.

This paper outlines the MRI-guided interventional radiotherapy (IRT) workflow at the authors' institution, providing a detailed pictorial guide to help radiologists implement this technique in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in cervical cancer interventional radiotherapy (brachytherapy): a pictorial essay focused on radiologist management. Russo, L., Lancellotta, V., Miccò, M., et al.[2022]

High-resolution endorectal magnetic resonance imaging (eMRI) improved the staging of cervical carcinoma in 39% of patients by identifying proximal vaginal involvement, which was not detected through standard examination methods.

The study found that tumors with bright signal characteristics on eMRI were associated with earlier disease stages, better hemoglobin levels, and higher rates of complete response to irradiation, suggesting that eMRI can provide valuable prognostic information to guide treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Signal characteristics of tumors shown by high-resolution endorectal coil magnetic resonance imaging may predict outcome among patients with cervical carcinoma treated with irradiation. A preliminary study. Corn, BW., Schnall, MD., Milestone, B., et al.[2005]

The study involving 40 patients with stages IB2 and II cervical cancer demonstrated that pulsed dose rate image-guided brachytherapy (PDR-IGBT) after concurrent chemoradiotherapy (CRT) is a feasible and effective treatment, achieving a local control rate of 90% and overall survival of 100% over a median follow-up of 30 months.

While the treatment was generally well-tolerated, some patients experienced acute and chronic adverse events, with 12.5% experiencing grade 3 to 4 gastrointestinal issues, indicating that while effective, monitoring for side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concomitant Chemoradiotherapy With Image-guided Pulsed Dose Rate Brachytherapy as a Definitive Treatment Modality for Early-stage Cervical Cancer. Refaat, T., Castelain, B., Small, W., et al.[2021]

In a study of 126 cervical cancer patients, 3D MRI-guided brachytherapy (IGBT) showed a trend towards improved local control and overall survival compared to 2D conventional brachytherapy (CBT), with local control rates of 93% after 1 year and 88% after 3 years.

The use of interstitial needles in IGBT allowed for higher doses to the high-risk clinical target volume while reducing radiation exposure to the bladder, resulting in decreased toxicity from 17% in the 2D cohort to 12% in the 3D cohort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of brachytherapy technique (2D versus 3D) on outcome following radiotherapy of cervical cancer. Derks, K., Steenhuijsen, JLG., van den Berg, HA., et al.[2022]

Endovaginal MRI (evMRI) using T2-weighted and ZOOM-diffusion-weighted imaging demonstrated high sensitivity (92.0%) and specificity (81.8%) for detecting stage Ia/Ib1 cervical cancer in a study of 57 patients, indicating its effectiveness in early cancer detection.

The imaging findings from evMRI led to changes in surgical management for approximately 39% of patients scheduled for radical vaginal trachelectomy, highlighting its potential impact on treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influencing surgical management in patients with carcinoma of the cervix using a T2- and ZOOM-diffusion-weighted endovaginal MRI technique. Downey, K., Jafar, M., Attygalle, AD., et al.[2022]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in cervical cancer interventional radiotherapy (brachytherapy): a pictorial essay focused on radiologist management. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Signal characteristics of tumors shown by high-resolution endorectal coil magnetic resonance imaging may predict outcome among patients with cervical carcinoma treated with irradiation. A preliminary study. [2005]

3. United States pubmed.ncbi.nlm.nih.gov

Concomitant Chemoradiotherapy With Image-guided Pulsed Dose Rate Brachytherapy as a Definitive Treatment Modality for Early-stage Cervical Cancer. [2021]

4. Poland pubmed.ncbi.nlm.nih.gov

Impact of brachytherapy technique (2D versus 3D) on outcome following radiotherapy of cervical cancer. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Influencing surgical management in patients with carcinoma of the cervix using a T2- and ZOOM-diffusion-weighted endovaginal MRI technique. [2022]