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MRI for Diagnosing Osteoradionecrosis in Head and Neck Cancer

N/A

Recruiting

Led By Stephen 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

COHORT 2 (ENRICHED): Subjects with recurrent and/or new head and neck cancer disease who will undergo re-irradiation to the head and neck with intent to eradicate the malignancy. Treatment criteria specified

COHORT 3 (EARLY ORN INTERVENTION): Subjects with clinically confirmed low-grade/early stage osteoradionecrosis requiring therapeutic intervention as diagnosed by a qualified clinician. Clinical staging criteria specified

Must not have

Unable to obtain imaging studies of adequate quality to assess imaging-based biomarkers

COHORT 1/GROUP 1: Previously treated with radiotherapy for a malignant neoplasm of the head and neck, excluding cutaneous lesions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses MRI to study how well it can diagnose osteoradionecrosis in patients with head and neck cancer undergoing radiation therapy.

Who is the study for?

This trial is for patients with head and neck cancer, either new or recurrent, who are undergoing radiation therapy. Participants must be willing to consent and follow study procedures throughout the duration. They should have a good performance status (able to carry out daily activities) and not have been diagnosed with osteoradionecrosis at enrollment. Exclusions include poor kidney function, claustrophobia, pregnancy, cognitive impairment, non-MRI compatible implants, or previous multiple radiotherapies for head and neck malignancies.

What is being tested?

The trial is testing how well dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) can predict bone damage caused by radiation therapy in patients with head and neck cancer. It involves different groups: those about to start radiation therapy; those already treated; those showing early signs of bone damage; and those needing surgery due to severe bone damage.

What are the potential side effects?

Potential side effects mainly relate to MRI procedure discomforts such as reactions to contrast agents used during DCE-MRI (like mild allergic reactions), feelings of claustrophobia inside the MRI machine, or issues related to lying still during the scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have recurring or new head and neck cancer and will undergo more radiation to try to cure it.

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I have early stage bone damage from radiation needing treatment.

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I have received radiation therapy aimed at curing my cancer, with or without chemotherapy.

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I am able to care for myself and perform daily activities.

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I am about to start or am currently receiving radiation, with or without chemotherapy, to try to cure my cancer.

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I need surgery for severe bone damage from radiation.

Exclusion Criteria

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

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I cannot get clear scans to check for specific cancer markers.

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I had radiotherapy for cancer in my head or neck, not including skin cancer.

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My kidney function is reduced with a GFR less than 60.

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I have had radiotherapy for head or neck cancer more than once, not including skin cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

DCE-MRI Derived Parameters Following External Beam Radiation Therapy (EBRT) and Subsequent Development of Osteoradionecrosis (ORN)

Secondary study objectives

Dose-Response Relationships Between DCE-MRI Derived Imaging Biomarkers and Subsequent Development of Osteoradionecrosis (ORN)

Side effects data

From 2013 Phase 2 trial • 44 Patients • NCT00227760

11%

Dyspnea

Headache

Infection and infestations - other

Back pain

Chest pain - cardiac

Dehydration

Myocardial infarction

Chest wall pain

Seizure

Hypoxia

Vascular disorder - other

Thromboembolic event

Syncope

Fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Cediranib Maleate)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4 (DCE-MRI)Experimental Treatment2 Interventions

Patients undergo DCE-MRI within 4 weeks prior to and at 5-10 weeks and 12 months post surgery.

Group II: Cohort 3 (DCE-MRI)Experimental Treatment2 Interventions

Patients undergo DCE-MRI before and at 2 and 6 months post ORN treatment. Patients may undergo DCE-MRI during the mid-ORN treatment.

Group III: Cohort 2 (DCE-MRI)Experimental Treatment2 Interventions

Patients undergo DCE-MRI within 4 weeks prior to the first re-radiation fraction, within 3-5 weeks after radiation start, and at 2, 6, 12, 24, and 36 months post radiation.

Group IV: Cohort 1 (DCE-MRI)Experimental Treatment2 Interventions

Patients with newly diagnosed tumors undergo DCE-MRI within 4 weeks prior to the first radiation fraction, within 3-5 weeks after radiation start, and at 2, 6, 12, 24, and 36 months post radiation. Patients who were previously irradiated and are at various stages of oncologic follow-up undergo DCE-MRI for a total of 2-5 times at baseline and at 6, 12, 24, 36, and/or 48 months post radiation. Patients in the third or subsequent years post treatment may undergo subsequent yearly imaging studies.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

2006

Completed Phase 2

~310

0 / 10Eligibility criteria met