Malignant Oral Cavity NeoplasmPhase 4NCT04265430
Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients With Oral Cavity or Skull Base Tumors
A Phase 4 study testing Contrast Agent, Magnetic Resonance Imaging and Quality-of-Life Assessment in people with Malignant Oral Cavity Neoplasm and Malignant Skull Base Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase IV trial studies how well serial magnetic resonance imaging (MRI) after radiation therapy works in predicting radiation-induced changes in the normal tissue of patients with oral cavity or skull base tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Oral Cavity Neoplasm, Malignant Skull Base Neoplasm, Osteoradionecrosis
- What is being tested?
- Contrast Agent, Magnetic Resonance Imaging and Quality-of-Life Assessment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2018to 1 Sep 2031
- Phase
- Phase 4
- 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
- All Cohorts:
- Patients older than 18 years of age
- Patients with good performance status (ECOG score 0-2)
- Patients willing to give written informed consent.
- Cohort 1 (Individuals without ORN or MRONJ):
- Patients with histologically proven malignant neoplasms of the oral cavity, oropharynx or skull base.
Show all 10Show fewer
- Patients currently dispositioned to treatment with radiotherapy and/or antiresorptive or antiangiogenic medication therapy
- Cohort 2 (Individuals with ORN or MRONJ):
- Patients with a clinical diagnosis of ORN or MRONJ following treatment for cancer
- Patients previously dispositioned to treatment with radiotherapy and/or antiresorptive or antiangiogenic medication therapy
Who cannot join
- Patients unable to tolerate DW-MRI or DCE-MRI or having an estimated GFR < 30ml/min/1.73m2.
- Patients with contraindication to MRI (e.g. non-MRI compatible metallic implants)
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
Stephen Y. Lai
About this study
Official title: Serial Magnetic Resonance Imaging of Longitudinal Radiotherapy-Attributable Normal Tissue Injury
This phase IV trial studies how well serial magnetic resonance imaging (MRI) after radiation therapy works in predicting radiation-induced changes in the normal tissue of patients with oral cavity or skull base tumors. Performing MRIs after radiation therapy for patients with oral cavity or skull base tumors may help to predict osteoradionecrosis (a change in non-cancerous tissue).
Read the detailed description
PRIMARY OBJECTIVES:
- Demonstrate the feasibility of serial magnetic resonance (MR) imaging biomarkers for assessment of early, intermediate, and late radiotherapy-attributable physiologic alteration of tumor and normal tissues and the kinetics thereof.
II. Develop MR-biomarker inclusive predictive models for development of radiotherapy-attributable normal tissue injury.
III. Define dose-response relationships between imaging biomarkers and subsequent radiation-induced effects.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients may receive a contrast agent intravenously (IV) and then undergo an MRI over 45-60 minutes at baseline, 3-5 weeks after starting standard of care radiation therapy, and then at 2 months, 6 months, 12 months, and 3 years after completing radiation therapy.
COHORT II: Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, and at 5-10 weeks and 12 months after standard of care surgery.
- Being tested
- Contrast Agent, Magnetic Resonance Imaging, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Mouth Neoplasms, Osteoradionecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast AgentOther
Also called Contrast, Contrast Drugs, contrast material, Contrast Medium
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI
Undergo MRI
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Cohort I (MRI after radiation therapy) | Experimental | Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, 3-5 weeks after starting standard of care radiation therapy, and then at 2 months, 6 months, 12 months, and 3 years after completing radiation therapy. Receives: Other: Contrast Agent; Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Cohort II (MRI after surgery) | Experimental | Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, and at 5-10 weeks and 12 months after standard of care surgery. Receives: Other: Contrast Agent; Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiotherapy-attributable imaging for normal tissue injury
Will correlate whether post-therapy alterations in the observed multi-parametric imaging features can be used as surrogate bio-markers of normal tissue injury
Measured: Up to 1 year
Dose-response correlation between imaging biomarkers
Penalized spline mixed regression will be used to characterize the induced functional relationships between the delivered dose and imaging biomarkers identified at each imaging time point. Doses for which 95% confidence interval estimates of mean trajectory fail to overlap will characterize ranges that yield significantly different levels of dose-dependent modulation.
Measured: Up to 1 year
Dose-response correlation between subsequent radiation-induced effects
Penalized spline mixed regression will be used to characterize the induced functional relationships between the delivered dose and imaging biomarkers identified at each imaging time point. Doses for which 95% confidence interval estimates of mean trajectory fail to overlap will characterize ranges that yield significantly different levels of dosedependent modulation
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start17 Sep 2018
- Primary completion1 Sep 2031 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Oral Cavity NeoplasmStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 425 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephen Y Lai, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265430
- Sponsor's protocol ID
- PA14-0807
- Other IDs
- NCI-2019-07862, PA14-0807
- Status last verified
- May 2026
- First submitted
- 3 Dec 2019
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Magnetic Resonance Imaging of Longitudinal Radiotherapy-Attributable Normal Tissue Injury
- ClinicalTrials.gov ID
- NCT04265430
- Acronym / sponsor ID
- PA14-0807
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 425 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 1 Sep 2031 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 11 Feb 2020 (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 phase IV trial studies how well serial magnetic resonance imaging (MRI) after radiation therapy works in predicting radiation-induced changes in the normal tissue of patients with oral cavity or skull base tumors. Performing MRIs after radiation therapy for patients with oral cavity or skull base tumors may help to predict osteoradionecrosis (a change in non-cancerous tissue).
Detailed description
PRIMARY OBJECTIVES:
- Demonstrate the feasibility of serial magnetic resonance (MR) imaging biomarkers for assessment of early, intermediate, and late radiotherapy-attributable physiologic alteration of tumor and normal tissues and the kinetics thereof.
II. Develop MR-biomarker inclusive predictive models for development of radiotherapy-attributable normal tissue injury.
III. Define dose-response relationships between imaging biomarkers and subsequent radiation-induced effects.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients may receive a contrast agent intravenously (IV) and then undergo an MRI over 45-60 minutes at baseline, 3-5 weeks after starting standard of care radiation therapy, and then at 2 months, 6 months, 12 months, and 3 years after completing radiation therapy.
COHORT II: Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, and at 5-10 weeks and 12 months after standard of care surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort I (MRI after radiation therapy) | Experimental | Other: Contrast Agent, Procedure: Magnetic Resonance Imaging, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, 3-5 weeks after starting standard of care radiation therapy, and then at 2 months, 6 months, 12 months, and 3 years after completing radiation therapy. |
| Cohort II (MRI after surgery) | Experimental | Other: Contrast Agent, Procedure: Magnetic Resonance Imaging, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, and at 5-10 weeks and 12 months after standard of care surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients older than 18 years of age
- Patients with good performance status (ECOG score 0-2)
- Patients willing to give written informed consent.
- Patients with histologically proven malignant neoplasms of the oral cavity, oropharynx or skull base.
- Patients currently dispositioned to treatment with radiotherapy and/or antiresorptive or antiangiogenic medication therapy
Key exclusion criteria (2 listed)
- Patients unable to tolerate DW-MRI or DCE-MRI or having an estimated GFR < 30ml/min/1.73m2.
- Patients with contraindication to MRI (e.g. non-MRI compatible metallic implants)
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 |
|---|---|---|
| Contrast AgentAlso: Contrast, Contrast Drugs, contrast material, Contrast MediumGiven IV | Other | Cohort I (MRI after radiation therapy), Cohort II (MRI after surgery) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRIUndergo MRI | Procedure or surgery | Cohort I (MRI after radiation therapy), Cohort II (MRI after surgery) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Cohort I (MRI after radiation therapy), Cohort II (MRI after surgery) |
| Questionnaire AdministrationAncillary studies | Other | Cohort I (MRI after radiation therapy), Cohort II (MRI after surgery) |
Primary outcome
Radiotherapy-attributable imaging for normal tissue injury
Time frame: Up to 1 year
Will correlate whether post-therapy alterations in the observed multi-parametric imaging features can be used as surrogate bio-markers of normal tissue injury
Dose-response correlation between imaging biomarkers
Time frame: Up to 1 year
Penalized spline mixed regression will be used to characterize the induced functional relationships between the delivered dose and imaging biomarkers identified at each imaging time point. Doses for which 95% confidence interval estimates of mean trajectory fail to overlap will characterize ranges that yield significantly different levels of dose-dependent modulation.
Dose-response correlation between subsequent radiation-induced effects
Time frame: Up to 1 year
Penalized spline mixed regression will be used to characterize the induced functional relationships between the delivered dose and imaging biomarkers identified at each imaging time point. Doses for which 95% confidence interval estimates of mean trajectory fail to overlap will characterize ranges that yield significantly different levels of dosedependent modulation
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 22 May 2026.
- MD Anderson Cancer CenterLink 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 Y 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 Phase 4 study testing Contrast Agent, Magnetic Resonance Imaging and Quality-of-Life Assessment in people with Malignant Oral Cavity Neoplasm and Malignant Skull Base Neoplasm, 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 10 inclusion and 2 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 22 May 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Y. 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?
Radiotherapy-attributable imaging for normal tissue injury (time frame: Up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.