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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

Must not have

Patients unable to tolerate diffusion weighted (DW)-MRI or dynamic contrast-enhanced (DCE)-MRI or having an estimated glomerular filtration rate (GFR) < 60 ml/min/1.73m^2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot undergo certain MRI scans or my kidney function is low.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

58700-Nystagmus

16800-Bladder infection

11600-Alanine aminotransferase increased

44800-Infections and infestations - Other specify

58300-Neutrophil count decreased

41400-Hyperglycemia(targeted toxicity)

69700-Rash maculo-papular(targeted toxicity)

33900-Fever

33300-Febrile neutropenia

20500-Catheter related infection

42600-Hypoalbuminemia

43100-Hypokalemia

88500-White blood cell decreased

41300-Hypercalcemia

42700-Hypocalcemia

15300-Ataxia

64400-Personality change

13200-Anemia

57600-Nausea(targeted toxicity)

13500-Anorexia

15000-Aspartate aminotransferase increased

25700-Diarrhea

41600-Hyperkalemia

41500-Hyperhidrosis

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Chemotherapy, Immunoglobulin Therapy)

Arm II (Chemotherapy, Observation)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

~1160

0 / 4Eligibility criteria met