NCT04452162

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Aug 2020Jun 2026

First Submitted

Initial submission to the registry

June 25, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 25, 2020

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

5.8 years

First QC Date

June 25, 2020

Last Update Submit

September 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Salivary Gland Tumor

OTHER
Diagnostic Test: MRI

Interventions

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.

Salivary Gland Tumor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Salivary Gland Neoplasms

Condition Hierarchy (Ancestors)

Mouth NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Study Officials

  • Sanjeev Chawla

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Research Professor of Radiology

Study Record Dates

First Submitted

June 25, 2020

First Posted

June 30, 2020

Study Start

August 25, 2020

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations