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

Trial Summary

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 data supports the effectiveness of the treatment MRI for salivary gland tumors?

MRI is effective for salivary gland tumors because it provides clear images that help doctors see the exact location and size of the tumors. It is better than other imaging methods like CT scans for identifying the tumor's borders and whether it has spread, which is crucial for planning treatment. ^{1 2 3 4 5}

Is MRI safe for use in humans?

MRI (Magnetic Resonance Imaging) is generally considered safe for humans. It is a non-invasive imaging technique that does not use ionizing radiation, making it safer than some other imaging methods like CT scans. ^{1 2 5 6 7}

How is MRI different from other treatments for salivary gland tumors?

MRI (Magnetic Resonance Imaging) is unique because it provides detailed images of salivary gland tumors, helping to determine if they are benign or malignant and their exact location and size. Unlike other treatments, MRI is non-invasive and does not involve radiation, making it safer for repeated use to monitor tumor changes over time. ^{1 3 8 9 10}

What is the purpose of this trial?

The goal of this study is to use advanced Magnetic Resonance Imaging (MRI) techniques to help identify the difference between cancerous and non-cancerous salivary gland tumors for improving treatment strategies and to aid in the prediction of disease progression.

Research Team

Sanjeev Chawla

Principal Investigator

Professor

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

References

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

State-of-the-Art Imaging of Salivary Gland Tumors. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

[Magnetic resonance tomography in tumors of the salivary glands--a diagnostic advantage?]. [2006]

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

Imaging tumors of the minor salivary glands. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Diffusion-weighted and gadolinium-enhanced dynamic MRI in parotid gland tumors. [2023]

5. Poland pubmed.ncbi.nlm.nih.gov

Differentiation of various salivary gland tumours using diffusion-weighted MRI and dynamic contrast-enhanced MRI. [2023]

6. Ireland pubmed.ncbi.nlm.nih.gov

MRI to quantify early radiation-induced changes in the salivary glands. [2015]

7. France pubmed.ncbi.nlm.nih.gov

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

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

Benign pleomorphic adenomas of the salivary glands: surface coil MR imaging versus CT. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of the parotid glands using inversion-recovery sequences at 0.08 T. [2006]

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

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