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MRI Monitoring for Oral Cancer

Phase 4
Recruiting
Led By Stephen Y Lai
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with good performance status (Eastern Cooperative Oncology Group [ECOG] score 0-2)
Patients with histologically proven malignant neoplasms of the oral cavity and skull base
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial looks at using MRIs to predict how radiation therapy will affect normal tissue in patients with oral or skull tumors.

Who is the study for?
This trial is for patients with confirmed malignant tumors in the oral cavity or skull base who have had or will have radiation therapy. They must be able to perform daily activities (ECOG score 0-2) and consent to participate. Those unable to undergo certain MRI scans, with poor kidney function, or incompatible implants cannot join.Check my eligibility
What is being tested?
The study is testing if serial MRIs after radiation can predict changes in non-cancerous tissue potentially leading to osteoradionecrosis in patients with oral cavity or skull base tumors. It involves contrast agents, quality-of-life assessments, and questionnaires.See study design
What are the potential side effects?
While not directly related to treatment side effects, participants may experience discomfort from the MRI procedure itself such as claustrophobia, loud noises during scanning, and potential allergic reactions to contrast agents used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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I have a confirmed cancer in my mouth or skull base.
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I have had or am having radiotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-response correlation between imaging biomarkers
Dose-response correlation between subsequent radiation-induced effects
Radiotherapy-attributable imaging for normal tissue injury

Side effects data

From 2022 Phase 3 trial • 53 Patients • NCT00033293
19%
87900-Vomiting(targeted toxicity)
15%
11400-Agitation
8%
11600-Alanine aminotransferase increased
8%
16800-Bladder infection
8%
44800-Infections and infestations - Other specify
8%
58700-Nystagmus
4%
15000-Aspartate aminotransferase increased
4%
88500-White blood cell decreased
4%
15300-Ataxia
4%
33900-Fever
4%
25700-Diarrhea
4%
43100-Hypokalemia
4%
69700-Rash maculo-papular(targeted toxicity)
4%
13200-Anemia
4%
33300-Febrile neutropenia
4%
57600-Nausea(targeted toxicity)
4%
20500-Catheter related infection
4%
58300-Neutrophil count decreased
4%
41300-Hypercalcemia
4%
41400-Hyperglycemia(targeted toxicity)
4%
41600-Hyperkalemia
4%
42600-Hypoalbuminemia
4%
42700-Hypocalcemia
4%
64400-Personality change
4%
41500-Hyperhidrosis
4%
13500-Anorexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Chemotherapy, Immunoglobulin Therapy)
Arm II (Chemotherapy, Observation)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort II (MRI after surgery)Experimental Treatment4 Interventions
Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, and at 5-10 weeks and 12 months after standard of care surgery.
Group II: Cohort I (MRI after radiation therapy)Experimental Treatment4 Interventions
Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, 3-5 weeks after starting standard of care radiation therapy, and then at 2 months, 6 months, 12 months, and 3 years after completing radiation therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,802,939 Total Patients Enrolled
5 Trials studying Oral Cancers
769 Patients Enrolled for Oral Cancers
National Cancer Institute (NCI)NIH
13,626 Previous Clinical Trials
40,927,210 Total Patients Enrolled
8 Trials studying Oral Cancers
1,904 Patients Enrolled for Oral Cancers
Stephen Y LaiPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
660 Total Patients Enrolled

Media Library

Magnetic Resonance Imaging Clinical Trial Eligibility Overview. Trial Name: NCT04265430 — Phase 4
Oral Cancers Research Study Groups: Cohort II (MRI after surgery), Cohort I (MRI after radiation therapy)
Oral Cancers Clinical Trial 2023: Magnetic Resonance Imaging Highlights & Side Effects. Trial Name: NCT04265430 — Phase 4
Magnetic Resonance Imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT04265430 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for recruitment into this experiment?

"Affirmative. The research posted on clinicaltrials.gov suggests that the medical trial is actively searching for participants. This initiative, which was initially published on September 17th 2018, requires 425 volunteers at one location to complete it's criteria."

Answered by AI

To what extent could Magnetic Resonance Imaging be hazardous to humans?

"MRI is deemed to be safe as a Phase 4 trial, thus receiving a score of 3."

Answered by AI

How many participants are enrolled in this clinical endeavor?

"Affirmative. Data posted on clinicaltrials.gov supports that this medical trial is currently recruiting participants, as it was last updated October 26th 2022 after being initially published September 17 2018. 425 individuals are targeted to be recruited from a single research location."

Answered by AI
~70 spots leftby Apr 2025