Salivary Gland TumorPSGTNCT04452162
Physiologic MR Imaging of Salivary Gland Tumors
A study testing MRI in people with Salivary Gland Tumor, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Salivary Gland Tumor
- What is being tested?
- MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2020to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Possess a salivary gland lesion of 1cm3 size
- Have no prior history of treatment for salivary gland lesion
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Marisa Sanchez, Marisa.Sanchez@pennmedicine.upenn.edu
Leeanne Lezotte, 856-364-3137, leeanne.lezotte@pennmedicine.upenn.edu
About this study
Official title: Physiologic MR Imaging in Distinguishing Benign From Malignant 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.
Read the 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.
- Conditions
- Salivary Gland Tumor
- Being tested
- MRI
- Medical subject headings
- Salivary Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Salivary Gland Tumor | Other | Not described Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differentiation and Progression Free
Differentiation of malignant from benign neoplasms and progression free survival at 6 month starting from end of chemo-radiation treatment
Measured: 6 Month after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start25 Aug 2020
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivary Gland TumorStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- McCabe Fund
- Responsible party
- Principal investigator, Sanjeev Chawla, University of Pennsylvania
- Investigators
- Sanjeev Chawla, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452162
- Sponsor's protocol ID
- 25319
- Other IDs
- 834242
- Acronym
- PSGT
- Status last verified
- Sep 2025
- First submitted
- 25 Jun 2020
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic MR Imaging in Distinguishing Benign From Malignant Salivary Gland Tumors
- ClinicalTrials.gov ID
- NCT04452162
- Acronym / sponsor ID
- PSGT / 25319
- Conditions
- Salivary Gland Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- McCabe Fund
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Salivary Gland Tumor | Other | Diagnostic Test: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Possess a salivary gland lesion of 1cm3 size
- Have no prior history of treatment for salivary gland lesion
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIYou 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. | Diagnostic test | Salivary Gland Tumor |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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Salivary Gland Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sanjeev Chawla principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Salivary Gland Tumor, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marisa Sanchez (2159019994, Marisa.Sanchez@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differentiation and Progression Free (time frame: 6 Month after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.