PET-MRI Imaging for Esophageal Cancer

Overseen By Rebecca [e-mail], MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Pregnancy, Pacemaker, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a single arm, single centre, investigator initiated study to investigate the feasibility of using PET-MRI imaging in radiation treatment workflow in up to 15 patients with esophagogastric cancer. PET-MRI imaging will be completed before the start of radiation treatment. MRI imaging will be completed during radiation treatment and after radiation treatment. These images will not be used to plan the radiation treatment and routine clinical care will be provided. The goal of this study is to gather information that will allow the radiation team to include MRI and PET imaging into the radiation treatment workflow for patients with esophageal cancer receiving radiation therapy in the future.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is PET-MRI imaging safe for humans?

PET-MRI imaging is generally considered safe for humans, as it combines two well-established imaging techniques, PET and MRI, which have been used safely in clinical settings. The lower radiation dose compared to PET/CT is particularly beneficial, especially for young patients. ^{1 2 3 4 5}

How does PET-MRI imaging differ from other treatments for esophageal cancer?

PET-MRI imaging is unique because it combines the detailed soft tissue contrast of MRI with the functional imaging capabilities of PET, allowing for better detection of small metastases and more accurate staging of esophageal cancer compared to traditional imaging methods like PET-CT. ^{5 6 7 8 9}

What data supports the effectiveness of the treatment PET-MRI for esophageal cancer?

Research shows that PET-MRI, which combines two imaging techniques, can improve the detection of cancer spread and help assess how well a treatment is working in esophageal cancer. It offers better imaging quality and can detect small metastases that might be missed by other methods, potentially leading to better treatment planning and outcomes. ^{5 7 10 11 12}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with locally advanced esophageal cancer who are about to start radiation therapy lasting more than 4 weeks. Participants must be able to consent and not be pregnant or breastfeeding. They can't have a pacemaker, defibrillator, severe claustrophobia, or issues with Gadolinium contrast used in MRI.

Inclusion Criteria

I have been diagnosed with advanced esophageal cancer and am considered for radiation therapy longer than 4 weeks.

Ability and willingness to provide written informed consent

Exclusion Criteria

Contraindication for MRI

I cannot lie on my back for at least 60 minutes.

Any patient who is pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Imaging

PET-MRI imaging is completed before the start of radiation treatment

1 week

Radiation Treatment

Participants receive radiation treatment with MRI imaging during the treatment

6-8 weeks

Post-Treatment Imaging

MRI imaging is completed after radiation treatment

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• PET-MRI

Trial Overview The study is testing the use of PET-MRI imaging as part of the treatment process for esophageal cancer patients receiving radiation therapy. It aims to see if incorporating this imaging before, during, and after treatment can improve future care.

How Is the Trial Designed?

Group I: PET-MRI Experimental Treatment 1 Intervention

PET-MRI in esophagogastric cancers

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Integrated PET/CT and MRI imaging technologies are enhancing the management of oesophageal cancer by improving the detection of metastatic disease and assessing treatment responses, which are crucial for effective patient care.

Recent advancements in MRI techniques, particularly diffusion-weighted imaging, are expected to complement PET/CT by providing better staging and treatment planning, ultimately leading to more personalized treatment strategies for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of oesophageal cancer with FDG-PET/CT and MRI. van Rossum, PSN., van Lier, ALHMW., Lips, IM., et al.[2022]

In a study of 54 patients with oesophageal squamous cell carcinoma (SCC), imaging biomarkers from PET/MRI scans were found to correlate with clinical stage and prognosis, indicating their potential use in predicting patient outcomes.

Specifically, a higher metabolic tumour volume (MTV) and a lower apparent diffusion coefficient (ADCmin) were associated with more advanced disease stages and shorter progression-free and overall survival, suggesting these biomarkers could help guide treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic value of 18F-FDG PET/MR imaging biomarkers in oesophageal squamous cell carcinoma. Yu, CW., Chen, XJ., Lin, YH., et al.[2020]

Integrated PET/MRI scanners provide significant advantages in imaging applications that require high soft tissue contrast and lower radiation doses, particularly benefiting cancer staging and tumor imaging.

This hybrid imaging modality shows promise in various oncological applications, as well as cardiac and brain imaging, while also being safer for young patients due to reduced radiation exposure compared to traditional PET/CT scans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of PET/MRI: current status and future perspectives. Nensa, F., Beiderwellen, K., Heusch, P., et al.[2021]

In a study of 40 patients with primary M0 esophageal squamous cell carcinoma, baseline and interim [18F]FDG-PET/MRI parameters, particularly total lesion glycolysis (TLG) and extracellular volume fraction (Ve), were effective in predicting treatment response and overall survival (OS).

The combination of interim TLG and Ve provided a better prognostic model for OS and progression-free survival (PFS) compared to the traditional TNM staging system, indicating that PET/MRI imaging can enhance treatment planning and patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline and interim [18F]FDG-PET/MRI to assess treatment response and survival in patients with M0 esophageal squamous cell carcinoma treated by curative-intent therapy. Chao, YK., Chang, CB., Chang, YC., et al.[2023]

Hybrid imaging techniques like PET-MRI combine the strengths of functional imaging (PET) and high-resolution soft tissue imaging (MRI), improving the detection of cancer metastases that traditional imaging methods may miss.

This review focuses on the clinical utility of FDG PET-MRI specifically for gastrointestinal cancers, highlighting its potential in diagnosing, staging, and assessing treatment responses for cancers such as esophageal, stomach, colorectal, and pancreatic cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Utility of Positron Emission Tomography Magnetic Resonance Imaging (PET-MRI) in Gastrointestinal Cancers. Matthews, R., Choi, M.[2020]

The introduction of combined PET/MRI systems at Rigshospitalet has shown promising results in imaging various types of cancer, including brain tumors and pediatric oncology, indicating that it performs well compared to traditional PET/CT imaging.

While initial clinical cases suggest that PET/MRI could enhance cancer diagnosis and treatment monitoring, further large-scale studies are necessary to determine the optimal use of this technology in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET/MRI in cancer patients: first experiences and vision from Copenhagen. Kjær, A., Loft, A., Law, I., et al.[2021]

Successful installation of PET/MRI systems requires careful planning and adherence to safety standards, including shielding for electromagnetic fields and gamma rays, as demonstrated through experiences with a SIEMENS Biograph mMR system.

Interdisciplinary collaboration among nuclear medicine, radiology, and other institutions is crucial for the effective operation of PET/MRI systems in both research and clinical environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical and organizational provision for installation, regulatory requirements and implementation of a simultaneous hybrid PET/MR-imaging system in an integrated research and clinical setting. Sattler, B., Jochimsen, T., Barthel, H., et al.[2021]

The study emphasizes the importance of understanding how a hybrid PET/MRI system can affect image quality, as certain parameters like PET quantification and MRI signal-to-noise ratio (SNR) can be altered when both systems are used together.

Developing specific corrections and calibrations for the combined PET/MRI system is crucial to ensure accurate and precise imaging results in small animal studies, highlighting the need for thorough exploration of the system before conducting experiments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluations of the performances of PET and MRI in a simultaneous PET/MRI instrument for pre-clinical imaging. Pollard, AC., de la Cerda, J., Schuler, FW., et al.[2022]

The integration of positron emission tomography (PET) with magnetic resonance (MR) imaging provides a comprehensive approach by combining detailed anatomical information from MR scans with biological and physiological data from PET scans.

Implementing a PET-MR imaging program involves addressing technical and operational challenges, including scheduling, workflow, and room construction, which are crucial for optimizing its clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Techniques, benefits, and challenges of PET-MR. Ocampo, T., Knight, K., Dunleavy, R., et al.[2015]

Whole-body MRI (WBMRI) demonstrated comparable accuracy to PET-CT in identifying primary esophageal tumors, detecting them in 98% of patients, compared to 94% for PET-CT, based on a study of 49 patients.

In nodal analysis, WBMRI showed improved sensitivity (59%) and accuracy (67%) compared to PET-CT (46% sensitivity, 59% accuracy) when including both surgical specimens and endoscopic ultrasound criteria, suggesting WBMRI may be a viable alternative for staging esophageal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole Body MRI in the Staging of Esophageal Cancer--A Prospective Comparison with Whole Body 18F-FDG PET-CT. Malik, V., Harmon, M., Johnston, C., et al.[2016]

The study evaluated the safety and efficacy of integrated 18F-FDG-PET/MRI in preoperative staging of 16 patients with oesophageal or gastroesophageal junctional cancer, finding no medical complications and high correlations in tumor measurements compared to the standard 18F-FDG-PET/CT.

While 18F-FDG-PET/MRI showed excellent correlation in maximum standardized uptake values (SUVmax) and substantial agreement in assessing nodal and metastatic stages, discrepancies were noted in T-stage classification, suggesting further investigation is needed to optimize its use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-FDG-PET/MRI in preoperative staging of oesophageal and gastroesophageal junctional cancer. Linder, G., Korsavidou-Hult, N., Bjerner, T., et al.[2020]

Endoluminal MRI was effective in accurately classifying the T stage of esophageal carcinoma in 8 out of 9 specimens, demonstrating its potential as a reliable imaging technique for tumor staging.

However, the accuracy of lymph node classification was lower, with only 67% correct TN classification, primarily due to limitations in the MRI's field of view, which missed many lymph nodes, including those with metastatic involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esophageal carcinoma. Ex vivo endoluminal magnetic resonance imaging. Stoker, J., van Velthuysen, ML., van Overhagen, H., et al.[2019]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Imaging of oesophageal cancer with FDG-PET/CT and MRI. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Prognostic value of 18F-FDG PET/MR imaging biomarkers in oesophageal squamous cell carcinoma. [2020]

3. Turkey pubmed.ncbi.nlm.nih.gov

Clinical applications of PET/MRI: current status and future perspectives. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Baseline and interim [18F]FDG-PET/MRI to assess treatment response and survival in patients with M0 esophageal squamous cell carcinoma treated by curative-intent therapy. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Utility of Positron Emission Tomography Magnetic Resonance Imaging (PET-MRI) in Gastrointestinal Cancers. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

PET/MRI in cancer patients: first experiences and vision from Copenhagen. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Physical and organizational provision for installation, regulatory requirements and implementation of a simultaneous hybrid PET/MR-imaging system in an integrated research and clinical setting. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Evaluations of the performances of PET and MRI in a simultaneous PET/MRI instrument for pre-clinical imaging. [2022]

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

Techniques, benefits, and challenges of PET-MR. [2015]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Whole Body MRI in the Staging of Esophageal Cancer--A Prospective Comparison with Whole Body 18F-FDG PET-CT. [2016]

11. England pubmed.ncbi.nlm.nih.gov

18F-FDG-PET/MRI in preoperative staging of oesophageal and gastroesophageal junctional cancer. [2020]

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

Esophageal carcinoma. Ex vivo endoluminal magnetic resonance imaging. [2019]