Physiologic MR Imaging of Salivary Gland Tumors

Salivary Gland Tumor Clinical Trial

— PSGT  

Official title:

Physiologic MR Imaging in Distinguishing Benign From Malignant Salivary Gland Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04452162
• Other study ID #: 25319
• Secondary ID: 834242
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2020
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Marisa Sanchez
• Phone: 2159019994
• Email: Marisa.Sanchez[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Salivary Gland Neoplasms
• Salivary Gland Tumor

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	McCabe Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differentiation and Progression Free	Differentiation of malignant from benign neoplasms and progression free survival at 6 month starting from end of chemo-radiation treatment	6 Month after the end of treatment