Head and Neck CancerNCT03145077
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
A study testing Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Questionnaire Administration in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2017to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Stephen Y. Lai, 713-792-6920, sylai@mdanderson.org
Stephen Y. Lai
About this study
Official title: Using Magnetic Resonance Imaging (MRI) to Assess Mandibular and Soft Tissue Responses to Radiation Therapy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine whether DCE-MRI following external beam radiation therapy (EBRT) can be used to reliably predict osteoradionecrosis (ORN).
SECONDARY OBJECTIVES:
- 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.
- 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
- Head and Neck Cancer
- Being tested
- Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Questionnaire Administration
- Keywords
- Head and Neck Cancer, Osteoradionecrosis, ORN, Dynamic contrast-enhanced magnetic resonance imaging, DCE-MRI, Questionnaires, Surveys
- Medical subject headings
- Head and Neck Neoplasms, Osteoradionecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Contrast-Enhanced Magnetic Resonance ImagingProcedure or surgery
Also called DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI
Undergo DCE-MRI
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (DCE-MRI) | Experimental | 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. Receives: Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Other: Questionnaire Administration |
| Cohort 2 (DCE-MRI) | Experimental | 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. Receives: Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Other: Questionnaire Administration |
| Cohort 3 (DCE-MRI) | Experimental | Patients undergo DCE-MRI before and at 2 and 6 months post ORN treatment. Patients may undergo DCE-MRI during the mid-ORN treatment. Receives: Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Other: Questionnaire Administration |
| Cohort 4 (DCE-MRI) | Experimental | Patients undergo DCE-MRI within 4 weeks prior to and at 5-10 weeks and 12 months post surgery. Receives: Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
DCE-MRI Derived Parameters Following External Beam Radiation Therapy (EBRT) and Subsequent Development of Osteoradionecrosis (ORN)
Spatiotemporal parameter maps extracted from patient DCE-MRI scans.
Clinical staging of developing or existing ORN conducted according to the CTCAE 4.0.
Measured: 5 years
Secondary outcomes (1)
Dose-Response Relationships Between DCE-MRI Derived Imaging Biomarkers and Subsequent Development of Osteoradionecrosis (ORN)
Voxel-by-voxel correlation of delivered radiation dose to mandible and DCE-MRI parameter changes determined to establish a dose-biomarker response relationship.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start21 Mar 2017
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Stephen Lai, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145077
- Sponsor's protocol ID
- PA16-0302
- Other IDs
- NCI-2018-02608, PA16-0302
- Status last verified
- Oct 2026
- First submitted
- 3 May 2017
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moreno A, Sahli AJ, Johnson F, Sun X, Barbon C, Rinsurongkawong W, Song W, Luciani FM, Liang H, Li J, Liu W, Lee JJ, Frank SJ, Lai S, Fuller C, Hutcheson K; P01 MD Anderson Oropharynx Cancer Program. Stiefel MD Anderson OroPharynx cancer (MDA-OPC) cohort: a single-institution, prospective longitudinal outcomes study. BMJ Open. 2025 Nov 24;15(11):e106845. doi: 10.1136/bmjopen-2025-106845.
PubMed 41290309
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Magnetic Resonance Imaging (MRI) to Assess Mandibular and Soft Tissue Responses to Radiation Therapy
- ClinicalTrials.gov ID
- NCT03145077
- Acronym / sponsor ID
- PA16-0302
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, Osteoradionecrosis, ORN, Dynamic contrast-enhanced magnetic resonance imaging, DCE-MRI, Questionnaires, Surveys
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To determine whether DCE-MRI following external beam radiation therapy (EBRT) can be used to reliably predict osteoradionecrosis (ORN).
SECONDARY OBJECTIVES:
- 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.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (DCE-MRI) | Experimental | Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Other: Questionnaire AdministrationPatients 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 (DCE-MRI) | Experimental | Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Other: Questionnaire AdministrationPatients 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 (DCE-MRI) | Experimental | Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Other: Questionnaire AdministrationPatients 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 (DCE-MRI) | Experimental | Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Other: Questionnaire AdministrationPatients undergo DCE-MRI within 4 weeks prior to and at 5-10 weeks and 12 months post surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Contrast-Enhanced Magnetic Resonance ImagingAlso: DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRIUndergo DCE-MRI | Procedure or surgery | Cohort 1 (DCE-MRI), Cohort 2 (DCE-MRI), Cohort 3 (DCE-MRI), Cohort 4 (DCE-MRI) |
| Questionnaire AdministrationAncillary studies | Other | Cohort 1 (DCE-MRI), Cohort 2 (DCE-MRI), Cohort 3 (DCE-MRI), Cohort 4 (DCE-MRI) |
Primary outcome
DCE-MRI Derived Parameters Following External Beam Radiation Therapy (EBRT) and Subsequent Development of Osteoradionecrosis (ORN)
Time frame: 5 years
Spatiotemporal parameter maps extracted from patient DCE-MRI scans. Clinical staging of developing or existing ORN conducted according to the CTCAE 4.0.
1 secondary outcome
Dose-Response Relationships Between DCE-MRI Derived Imaging Biomarkers and Subsequent Development of Osteoradionecrosis (ORN)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Derived from this study: PubMed 41290309Moreno A, Sahli AJ, Johnson F, Sun X, Barbon C, Rinsurongkawong W, Song W, Luciani FM, Liang H, Li J, Liu W, Lee JJ, Frank SJ, Lai S, Fuller C, Hutcheson K; P01 MD Anderson Oropharynx Cancer Program. Stiefel MD Anderson OroPharynx cancer (MDA-OPC) cohort: a single-institution, prospective longitudinal outcomes study. BMJ Open. 2025 Nov 24;15(11):e106845. doi: 10.1136/bmjopen-2025-106845.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen Lai principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Questionnaire Administration in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen> Lai (713-792-6920, sylai@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DCE-MRI Derived Parameters Following External Beam Radiation Therapy (EBRT) and Subsequent Development of Osteoradionecrosis (ORN) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03145077, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.