An interventional study of Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Questionnaire Administration in Head and Neck Cancer, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Diagnostic
Among 74 studies in Head and Neck Neoplasms by M.D. Anderson Cancer Center — 8 open to participants now, 21 under way, 1 of them phase 3. Head and Neck Neoplasms · M.D. Anderson Cancer Center.
Among the 74 studies in Head and Neck Neoplasms by M.D. Anderson Cancer Center, this one has the largest planned enrollment of the 56 interventional ones that give a count, is one of 4 that started in 2017, is one of 17 with no phase, reaches primary completion later than 11 of the 20 other live ones, and was the 57th registered.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
Browse Head and Neck Neoplasms studies →8 of the 74 studies in Head and Neck Neoplasms by M.D. Anderson Cancer Center are open now, in 1 country. Recruiting first, the newest first:
M.D. Anderson Cancer Center · Sites in United States
M.D. Anderson Cancer Center · Sites in United States
M.D. Anderson Cancer Center · Sites in United States
M.D. Anderson Cancer Center · Sites in United States
M.D. Anderson Cancer Center · Sites in United States
By country, each count listing its studies:
Of the 453 Head and Neck Neoplasms studies recruiting now, 345 (76%) set no upper age limit and 51 (11%) stop at 75 or younger; 21 take children under 18; 27 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
74 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 17 · Phase 2 25 · Phase 3 3
First in 1994; this study’s year is marked. 4 started in 2017.
This study's planned enrollment of 1,400 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Median enrollment 25 across the 56 interventional studies, 205 across the 18 observational. Of the 40 that completed or were terminated, 17 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.
Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.
15 of the studies in Head and Neck Neoplasms by M.D. Anderson Cancer Center that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01266044Phase 3M.D. Anderson Cancer CenterControlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia | 2026-12-31 |
| NCT04003051M.D. Anderson Cancer CenterWeb-Based Program in Helping Patients With Head and Neck Cancer Adhere to Swallowing Exercises and Coping Strategies | 2026-12-31 |
| NCT00498875M.D. Anderson Cancer CenterDepression and Adherence in Head and Neck Cancer | 2026-12-31 |
| NCT03224000M.D. Anderson Cancer CenterTrial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer | 2026-12-31 |
| NCT06237881M.D. Anderson Cancer CenterA Phase 1/2 Study of KSQ-001EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate the SOCS1 Gene, in Patients With Select Advanced Solid Tumors | 2027-01-01 |
Among the 74 studies in Head and Neck Neoplasms by M.D. Anderson Cancer Center, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging · Other: Questionnaire Administration
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.
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging · Other: Questionnaire Administration
Patients undergo DCE-MRI before and at 2 and 6 months post ORN treatment. Patients may undergo DCE-MRI during the mid-ORN treatment.
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging · Other: Questionnaire Administration
Patients undergo DCE-MRI within 4 weeks prior to and at 5-10 weeks and 12 months post surgery.
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging · Other: Questionnaire Administration
Undergo DCE-MRI
Also known as: DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI
Ancillary studies
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.
Time frame: 5 years
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.
Time frame: 5 years
Started Mar 2017 (actual). Primary completion is estimated for May 2027, 122 months after the start.
Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 122 months is above that.
Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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