MRI for Salivary Gland Tumors

(PSGT Trial)

Overseen By Marisa Sanchez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Cancer history, Renal disease, Pregnancy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance doctors' ability to distinguish between cancerous and non-cancerous tumors in the salivary glands using advanced MRI (Magnetic Resonance Imaging) scans. Researchers hope this will improve predictions of tumor behavior and lead to better treatment plans. The trial is open to individuals with a salivary gland lump at least the size of a small marble who have not yet received treatment for it. As an unphased trial, participants can contribute to groundbreaking research that may improve future diagnostic and treatment strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that MRI is safe for identifying salivary gland tumors?

Research shows that MRI (Magnetic Resonance Imaging) safely and comfortably examines salivary gland tumors. MRI uses magnets and radio waves to create images of the body's interior, avoiding radiation and enhancing safety.

Studies have demonstrated that MRI accurately distinguishes between benign (non-cancerous) and malignant (cancerous) tumors in the salivary glands. For instance, one study found that MRI was 90% accurate in determining whether a tumor in the parotid gland (a salivary gland near the ear) was benign or malignant. This finding indicates that MRI is both safe and effective for diagnosing these tumors.

Overall, MRI is a common tool in medicine because it is non-invasive and usually doesn't cause side effects. This makes it a safe option for patients considering participation in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using MRI for salivary gland tumors because it offers a non-invasive way to examine these tumors with incredible detail. Unlike traditional methods, such as biopsies or CT scans, MRI doesn't require any cutting or exposure to radiation. This makes it safer for patients and can provide clearer images to help doctors better understand the tumor's size and location. Ultimately, MRIs could lead to more accurate diagnoses and personalized treatment plans.

What evidence suggests that MRI is effective for identifying salivary gland tumors?

Research has shown that MRI, which participants in this trial will undergo, excels at diagnosing salivary gland tumors. Studies indicate that MRI accurately distinguishes between non-cancerous and cancerous tumors in the parotid gland, a major salivary gland, 90% of the time. MRI provides more detailed images than other scans, making it the best choice for assessing tumor spread. This advanced imaging helps doctors create better treatment plans by clearly showing the tumor's size and location. While some new techniques are still in development, MRI remains a dependable tool for understanding salivary gland tumors. ^{1 2 3 6 7}

Who Is on the Research Team?

Sanjeev Chawla

Principal Investigator

Professor

Are You a Good Fit for This Trial?

This clinical trial is for individuals with salivary gland lesions at least 1cm3 in size, who haven't had any treatment for these lesions before. It's not suitable for pregnant individuals, those with a history of cancer (other than salivary gland tumors), people with conditions that make MRI unsafe, kidney disease patients, or anyone who has received radiation therapy to the head and neck.

Inclusion Criteria

I have a salivary gland lesion that is at least 1cm3 in size.

I have never been treated for a salivary gland issue.

Exclusion Criteria

Is pregnant

I have had radiation treatment to my head or neck before.

I have a history of kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo advanced MRI techniques to distinguish between benign and malignant salivary gland tumors

1 week

1 visit (in-person)

Follow-up

Participants are monitored for differentiation of malignant from benign neoplasms and progression-free survival

6 months

What Are the Treatments Tested in This Trial?

Interventions

• MRI

Trial Overview The study is testing advanced MRI techniques to distinguish between benign (non-cancerous) and malignant (cancerous) salivary gland tumors. The aim is to improve treatment decisions and predict how the disease may progress over time.

How Is the Trial Designed?

Group I: Salivary Gland Tumor Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

McCabe Fund

Collaborator

Trials

2

Recruited

80+

Published Research Related to This Trial

Magnetic resonance imaging (MRI) at 1.5 T provided clearer visualization of salivary gland tumors compared to CT, showing sharp tumor margins and no signs of invasion in all three cases, which were confirmed as benign pleomorphic adenomas.

While CT was able to identify two of the tumors, it required additional techniques like CT sialography for accurate assessment, highlighting MRI's superior capability in distinguishing tumor characteristics and potential invasiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benign pleomorphic adenomas of the salivary glands: surface coil MR imaging versus CT. Mirich, DR., McArdle, CB., Kulkarni, MV.[2019]

MRI using inversion-recovery pulse sequences effectively localized tumor masses in the salivary glands and provided clear visualization of blood vessels, aiding in assessing their relationship to critical structures like the facial nerve.

While MRI could not distinguish between different types of malignant cells or invasive tumors versus chronic inflammation, it successfully differentiated conditions such as parotitis from Mikulicz's disease and identified cysts and pleomorphic adenomas based on their imaging characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of the parotid glands using inversion-recovery sequences at 0.08 T. Smith, FW., Deans, HE., McLay, KA., et al.[2006]

Magnetic resonance imaging (MRI) is highly effective in visualizing tumors of the parotid gland, accurately identifying their location and extent, especially in malignant cases.

MRI plays a crucial role in detecting recurrent pleomorphic adenomas, although the specific histological nature of the tumors still requires confirmation through histological examination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[MRI in the diagnosis of tumors of the parotid gland]. Freling, NJ.[2006]

MRI is the most effective imaging method for characterizing parotid gland tumors, providing detailed information about their internal structure and relationship with surrounding tissues.

The use of functional MRI techniques, such as diffusion-weighted imaging and dynamic contrast-enhanced MRI, enhances the accuracy of tumor differentiation, despite increasing the workload for radiologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiparametric Magnetic Resonance Imaging for the Diagnosis and Differential Diagnosis of Parotid Gland Tumors. Gökçe, E.[2021]

In a study of 18 oropharyngeal cancer patients, MRI revealed significant radiation-induced changes in salivary glands 6 weeks after treatment, including a 25% reduction in gland volume and changes in signal intensity indicating increased water content, likely due to edema.

The study found a correlation between the changes in MRI signals and the radiation dose received, suggesting that higher doses may lead to more pronounced effects on salivary gland function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI to quantify early radiation-induced changes in the salivary glands. Houweling, AC., Schakel, T., van den Berg, CA., et al.[2015]

In a study of 40 patients with palpable salivary gland masses, magnetic resonance imaging (MRI) was found to be superior to computed tomography (CT) in both identifying primary lesions and diagnosing local and regional recurrences.

MRI provides better contrast resolution and specificity, especially when using gadolinium-DTPA as a contrast medium, allowing for clear differentiation of small intraglandular and periglandular masses from surrounding tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Magnetic resonance tomography in tumors of the salivary glands--a diagnostic advantage?]. Mees, K., Vogl, T., Kellermann, O.[2006]

Magnetic Resonance (MR) imaging is the preferred method for evaluating salivary gland tumors, providing precise localization and extension details, especially when using postcontrast techniques.

Multiparametric imaging, including diffusion-weighted and dynamic contrast-enhanced MR imaging, is effective in distinguishing between benign and malignant tumors, aiding in preoperative planning and monitoring for recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State-of-the-Art Imaging of Salivary Gland Tumors. Abdel Razek, AAK., Mukherji, SK.[2018]

Magnetic resonance imaging (MRI) was found to be superior to computed tomography (CT) in evaluating minor salivary gland tumors, providing better visualization of tumor margins and internal architecture.

The study of nine confirmed tumors showed that malignant tumors typically had irregular margins, while benign tumors had well-defined margins, indicating that MRI findings closely correlated with histopathological results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging tumors of the minor salivary glands. Kaneda, T., Minami, M., Ozawa, K., et al.[2019]

In a study of 32 patients with salivary gland tumors, dynamic contrast-enhanced MRI (DCE-MRI) parameters, especially the time signal intensity curves (TIC), Kep, and Ktrans, were found to be highly effective in differentiating between benign and malignant tumors, achieving an accuracy of up to 96.77%.

Diffusion-weighted MRI (DW-MRI) parameters were less effective in distinguishing between benign and malignant tumors but were useful in identifying specific tumor types, with mean ADC being particularly effective for pleomorphic adenomas and Warthin tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differentiation of various salivary gland tumours using diffusion-weighted MRI and dynamic contrast-enhanced MRI. Kushwaha, M., Kumar, J., Garg, A., et al.[2023]

A study of 133 patients showed that using a combination of diffusion-weighted imaging and dynamic contrast-enhanced MRI can achieve over 90% sensitivity in detecting malignant parotid gland tumors, making it a highly effective diagnostic tool.

This multiparametric MRI approach not only differentiates between benign and malignant tumors but also helps characterize specific types like pleomorphic adenomas and Warthin tumors, potentially reducing the need for invasive procedures like fine-needle aspiration in clear cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diffusion-weighted and gadolinium-enhanced dynamic MRI in parotid gland tumors. Pâris, P., Fath, L., Schultz, P., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9453317/

Advanced magnetic resonance imaging findings in salivary ... Core Tip: Conventional magnetic resonance imaging (MRI) provides more data than other radiological modalities in determining the extent of tumor ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S187972962300159X

Diagnostic imaging of salivary gland cancers: REFCOR ... In a study of 78 patients with recurrence, FDG PET was positive in 74 cases, with a false negative rate of 5.1%. Compared to conventional imaging, FDG PET ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4288916/

The Efficacy of Magnetic Resonance Imaging and Color ... The overall accuracy of MRI and color doppler ultrasonography in determining tumor site was 100% and 95%, respectively. No significant difference observed ...

4. radiooncologyjournal.com radiooncologyjournal.com/journals/jro/jro-aid1026.php

Diagnostic accuracy of Magnetic Resonance Imaging to ... The diagnostic accuracy of MRI to differentiate benign and malignant parotid gland tumours was 90%. These results were taken against surgery histopathology as a ...

5. mdpi.com mdpi.com/2072-6694/14/23/5804

Radiomics for Discriminating Benign and Malignant ... MRI radiomics shows promise in discriminating salivary gland tumors (SGTs) but a consistent radiomics signature has not emerged, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1852309/

Neither MRI, CT nor US is superior to diagnose tumors in the ... None of the examined imaging procedures MRI, CT or US is superior to diagnose a tumor in the salivary glands, but all imaging procedures allow ...

7. head-face-med.biomedcentral.com head-face-med.biomedcentral.com/articles/10.1186/s13005-024-00467-5

MRI and CT imaging characteristics in parotid tumors with ... Imaging characteristics, such as irregular shape and invasion may indicate towards malignant parotid tumors, even in patients with false-negative benign ...