Physiologic MR Imaging of Salivary Gland Tumors

NCT ID: NCT04452162

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-25

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Salivary Gland Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Salivary Gland Tumor

Group Type OTHER

MRI

Intervention Type 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.

Interventions

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MRI

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McCabe Fund

UNKNOWN

Sponsor Role collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Sanjeev Chawla

Assistant Research Professor of Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sanjeev Chawla

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Marisa Sanchez

Role: CONTACT

2159019994

Lisa Desiderio

Role: CONTACT

610-721-3365

Facility Contacts

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Marisa Sanchez

Role: primary

Leeanne Lezotte

Role: backup

856-364-3137

Other Identifiers

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834242

Identifier Type: OTHER

Identifier Source: secondary_id

25319

Identifier Type: -

Identifier Source: org_study_id

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