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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-21

Study Completion Date

2027-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This trial studies how well dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) works 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 who are undergoing radiation therapy. DCE-MRI may help doctors to predict osteoradionecrosis in patient with head and neck cancer undergoing radiation therapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Diffusion MRI for Head and Neck Cancer

NCT04251481

Head Cancer Neck

ACTIVE_NOT_RECRUITING NA

Dynamic Contrast Enhanced Computed Tomography (CT) for Head and Neck Cancer

NCT01549379

Head and Neck Cancer

TERMINATED NA

Quantitative MR Imaging in Locally Advanced Cervical Cancer

NCT03210428

Neoplasms Functional Magnetic Resonance Imaging Radiotherapy

UNKNOWN

DECT in Imaging Patients With Solid Organ Cancer With Intracranial Metastasis

NCT03685539

Malignant Neoplasm Metastatic Malignant Neoplasm in the Brain

COMPLETED NA

Standard and Delayed FDG PET/CT After Chemoradiation Therapy in Assessing Patients With Metastatic Head and Neck Squamous Cell Cancer

NCT03575949

Metastatic Head and Neck Squamous Cell Carcinoma Metastatic Malignant Neoplasm in the Spine

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. To determine whether DCE-MRI following external beam radiation therapy (EBRT) can be used to reliably predict osteoradionecrosis (ORN).

SECONDARY OBJECTIVES:

I. Define dose-response relationships between DCE-MRI derived imaging biomarkers and subsequent development of ORN.

II. Evaluate the use of DCE-MRI parameters to monitor ORN response to treatment.

III. Assess the use of DCE-MRI parameters in preoperative planning in advanced ORN subjects.

IV. Develop MRI-based biomarkers inclusive predictive models for development of radiotherapy-attributable tissue injury within the field of radiation.

V. Determine the association of patient-related outcomes (PROs) to clinical and imaging findings of tissue damage, such as the onset of ORN.

OUTLINE: Patients are assigned to 1 of 4 cohorts.

COHORT 1: 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.

COHORT 2: 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.

COHORT 3: Patients undergo DCE-MRI before and at 2 and 6 months post ORN treatment. Patients may undergo DCE-MRI during the mid-ORN treatment.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1 (DCE-MRI)

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.

Group Type EXPERIMENTAL

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo DCE-MRI

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Cohort 2 (DCE-MRI)

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 Type EXPERIMENTAL

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo DCE-MRI

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Cohort 3 (DCE-MRI)

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 Type EXPERIMENTAL

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo DCE-MRI

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Cohort 4 (DCE-MRI)

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

Group Type EXPERIMENTAL

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo DCE-MRI

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Undergo DCE-MRI

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DCE MRI DCE-MRI DYNAMIC CONTRAST ENHANCED MRI

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Willing and able to provide informed consent
* Patients must have histologic evidence of malignant neoplasm that may have been obtained from the primary tumor or metastatic lymph node
* Receipt of external beam radiation therapy (EBRT) with curative intent, with or without concomitant chemotherapy
* Good performance status (Eastern Cooperative Oncology Group \[ECOG\] score 0-2)
* Willing to comply with all study procedures; and
* Willing to participate for the duration of the study
* COHORT 1 (LONGITUDINAL) GROUP 1 (PRE-RADIATION): Subjects who are currently undergoing or scheduled to undergo treatment with radiotherapy with or without chemotherapy (induction or concurrent) with intent to eradicate the malignancy. Treatment will include the following: 1) primary or nodal disease adjacent to (within 2 cm) the mandible (i.e., likely to receive a dose of at least 50 Gy to some portion of the mandible volumes) and 2) \> 60% probability of survival for 3 years after treatment
* COHORT 1 (LONGITUDINAL) GROUP 2 (POST-RADIATION): Subjects who were previously treated with radiotherapy with or without chemotherapy (induction or concurrent). Treatment will have included the following: 1) unilateral maximum mandible dose of \>= 60 Gy and a gradient of dose across the mandible of \>= 20 Gy, 2) oncological cure and now in disease surveillance; and 3) no clinically diagnosed ORN at the time of enrollment
* 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 will include the following: 1) any mandible dose of at least 50 Gy cumulative (initial and subsequent treatment); and 2) no clinically diagnosed ORN at the time of enrollment
* COHORT 3 (EARLY ORN INTERVENTION): Subjects with clinically confirmed low-grade/early stage osteoradionecrosis requiring therapeutic (medical and/or dental surgery) intervention as diagnosed by a qualified clinician. Clinical staging of developing or existing ORN will be conducted using the CTCAE 4.0 (Common Terminology Criteria for Adverse Events)
* COHORT 4 (SURGICAL INTERVENTION FOR ADVANCED ORN): Subjects with clinically confirmed high grade/high stage osteoradionecrosis requiring surgical intervention. Clinical staging of ORN will be conducted using the CTCAE 4.0 (Common Terminology Criteria for Adverse Events)

Exclusion Criteria

* Unable to tolerate diffusion weighted (DW)-MRI or DCE-MRI
* Having an estimated glomerular filtration rate (GFR) \< 60 ml/min/1.73 m\^2
* Contraindication to MRI (e.g. non-MRI compatible metallic implants)
* Pregnant females and cognitively impaired patients
* Unable or unwilling to give written, informed consent to undergo MRI imaging
* Claustrophobia
* 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. Determination will be made by review of the radiation therapy plan and dosimetry map to evaluate mandible exposure to radiation
* COHORT 1/GROUP 2: Previously treated with radiotherapy for a malignant neoplasm of the head and neck more than one time, excluding cutaneous lesions

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No