← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

I have early stage bone damage from radiation needing treatment.

Select...

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

Select...

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

Select...

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

Select...

I need surgery for severe bone damage from radiation.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Chest pain - cardiac

Back pain

Dehydration

Myocardial infarction

Hypoxia

Seizure

Chest wall pain

Vascular disorder - other

Thromboembolic event

Syncope

Fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Cediranib Maleate)

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 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,931,753 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,803,381 Total Patients Enrolled

National Institute of Dental and Craniofacial Research (NIDCR)NIH

300 Previous Clinical Trials

847,212 Total Patients Enrolled

Media Library

Dynamic Contrast-Enhanced Magnetic Resonance Imaging Clinical Trial Eligibility Overview. Trial Name: NCT03145077 — N/A

Head and Neck Cancers Research Study Groups: Cohort 2 (DCE-MRI), Cohort 4 (DCE-MRI), Cohort 3 (DCE-MRI), Cohort 1 (DCE-MRI)

Head and Neck Cancers Clinical Trial 2023: Dynamic Contrast-Enhanced Magnetic Resonance Imaging Highlights & Side Effects. Trial Name: NCT03145077 — N/A

Dynamic Contrast-Enhanced Magnetic Resonance Imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT03145077 — N/A

Frequently Asked Questions

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

Are enrollment opportunities still available for this experiment?

"Indeed, clinicaltrials.gov reflects that this trial is currently recruiting participants since its posting on March 21st 2017 and later update in December 5th 2022. The study requires a total of 1400 patients from 1 site."

Answered by AI

How many individuals have enrolled in this experiment?

"Affirmative. Clinicaltrials.gov's data reveals that the medical study, which was initiated on March 21st 2017 is still searching for participants. 1400 patients must be admitted at a single site to complete the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Diagnosing Osteoradionecrosis in Patients With Head and Neck Cancer That Is Primary, Has Come Back, or Has Spread to Other Places in the Body

2017. "Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Diagnosing Osteoradionecrosis in Patients With Head and Neck Cancer That Is Primary, Has Come Back, or Has Spread to Other Places in the Body". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03145077.