Physiologic MR Imaging of Salivary Gland Tumors (PSGT)
Primary Purpose
Salivary Gland Tumor
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Salivary Gland Tumor
Eligibility Criteria
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
Sites / Locations
- Hospital of the University of PennsylvaniaRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Salivary Gland Tumor
Arm Description
Outcomes
Primary Outcome Measures
Differentiation and Progression Free
Differentiation of malignant from benign neoplasms and progression free survival at 6 month starting from end of chemo-radiation treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT04452162
First Posted
June 25, 2020
Last Updated
August 3, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
McCabe Fund
1. Study Identification
Unique Protocol Identification Number
NCT04452162
Brief Title
Physiologic MR Imaging of Salivary Gland Tumors
Acronym
PSGT
Official Title
Physiologic MR Imaging in Distinguishing Benign From Malignant Salivary Gland Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
McCabe Fund
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Salivary Gland Tumor
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Salivary Gland Tumor
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Intervention Description
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 Outcome Measure Information:
Title
Differentiation and Progression Free
Description
Differentiation of malignant from benign neoplasms and progression free survival at 6 month starting from end of chemo-radiation treatment
Time Frame
6 Month after the end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marisa Sanchez
Phone
2159019994
Email
Marisa.Sanchez@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Desiderio
Phone
610-721-3365
Email
lisa.desiderio@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjeev Chawla
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marisa Sanchez
Email
Marisa.Sanchez@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Leeanne Lezotte
Phone
856-364-3137
Email
leeanne.lezotte@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Sanjeev Chawla
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Physiologic MR Imaging of Salivary Gland Tumors
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