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NCT Number: NCT04452162

Physiologic MR Imaging of Salivary Gland Tumors

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.

Recruiting

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Key information

Conditions

Salivary Gland Tumor Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Salivary Gland Diseases Salivary Gland Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Leeanne Lezotte

CONTACT

[email protected]

856-364-3137

Marisa Sanchez

CONTACT

[email protected]

Sanjeev Chawla

PRINCIPAL_INVESTIGATOR

About this study

The goal of this proposed study is to investigate the potential utility of combined analysis of parameters (Ktrans, ti and ADC) in discriminating benign from malignant salivary glands tumors (SGTs). A total of 30 treatment naïve patients suspicious of SGT as observed on clinical evaluation and prior routine CT, MRI, Ultrasound, FNAC and/or PET will undergo 3T MRI. The MRI protocol will include acquisition of anatomical images with and without contrast agent injection, diffusion imaging and dynamic contrast enhanced-MRI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Possess a salivary gland lesion of 1cm3 size
  • Have no prior history of treatment for salivary gland lesion

Exclusion criteria

  • Has any prior history of cancer other than SGT
  • Has any MRI contra-indications
  • Has a history of known renal disease.
  • Has history of prior radiation to head and neck region
  • Is pregnant

Treatment and study plan

MRI

Diagnostic Test

You are being asked to complete one research MRI scan with and without contrast since your most recent clinical evaluation and/or prior imaging has shown the presence of a suspicious salivary gland tumor, prior to your scheduled upcoming surgery. MRI contrast agents act like a dye to make MRI pictures brighter and easier to read. During each MRI scan, you will have an intravenous line (IV line) placed. The IV line allows the contrast agent to be injected into your vein. If you have a history of renal disease you may be asked to complete a blood draw of approximately 2.5cc (½ teaspoon), for glomerular filtration rate (GFR) assessment for participation into the study.

Primary outcomes

  1. Differentiation and Progression Free

    Time frame: 6 Month after the end of treatment

    Differentiation of malignant from benign neoplasms and progression free survival at 6 month starting from end of chemo-radiation treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Desiderio

CONTACT

[email protected]

610-721-3365

Marisa Sanchez

CONTACT

[email protected]

2159019994

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • McCabe Fund

Registry information

Official study title

Physiologic MR Imaging in Distinguishing Benign From Malignant Salivary Gland Tumors

Acronym: PSGT

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2020
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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