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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04265430
Other study ID # PA14-0807
Secondary ID NCI-2019-07862PA
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 17, 2018
Est. completion date April 30, 2025

Study information

Verified date May 2024
Source M.D. Anderson Cancer Center
Contact Stephen Y. Lai
Phone 713-792-6920
Email sylai@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


Description:

PRIMARY OBJECTIVES: I. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 425
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with histologically proven malignant neoplasms of the oral cavity and skull base - Patients whom, currently or previously, dispositioned to treatment with radiotherapy - Patients with good performance status (Eastern Cooperative Oncology Group [ECOG] score 0-2) - Patients willing to give written informed consent Exclusion Criteria: - Patients unable to tolerate diffusion weighted (DW)-MRI or dynamic contrast-enhanced (DCE)-MRI or having an estimated glomerular filtration rate (GFR) < 60 ml/min/1.73m^2 - Patients with contraindication to MRI (e.g. non-MRI compatible metallic implants)

Study Design


Intervention

Other:
Contrast Agent
Given IV
Procedure:
Magnetic Resonance Imaging
Undergo MRI
Other:
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Up to 1 year
Primary 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. Up to 1 year
Primary 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 Up to 1 year
See also
  Status Clinical Trial Phase
Terminated NCT00989820 - Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis Phase 2/Phase 3
Completed NCT01147315 - ORN Study: Curative Treatment of Osteoradionecrosis (ORN) With Hybrid Bone Substitution N/A
Not yet recruiting NCT06055257 - Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Mandible Phase 3
Recruiting NCT04934644 - The Effect of Hyperbaric Oxygen Treatment in Patients With Osteoradionecrosis. N/A
Active, not recruiting NCT04009161 - Osteoradionecrosis Rate in Patients Undergoing Radiotherapy for Head and Neck Cancer Treatment.
Completed NCT06428994 - Risk for Subsequent Osteoradionecrosis in A Transferred Fibula Flap in Head and Neck Cancer Patients Undergoing Segmental Mandibulectomy: a Cohort Study
Recruiting NCT02661139 - Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction
Recruiting NCT00760682 - Hyperbaric Oxygen Treatment of Mandibular Osteoradionecrosis. A Randomized Clinical Study Phase 2
Recruiting NCT05412849 - Radiation Field, Dose and Fractionation Related to Mandibular Complications
Completed NCT02368457 - Management of Mandibular ORN: PENTO as Medical Treatment Phase 4
Active, not recruiting NCT05325970 - Clinical Registry of Long-Term Dental Outcomes in Head and Neck Cancer Patients
Active, not recruiting NCT02057510 - Observational Study of Dental Outcomes in Head and Neck Cancer Patients
Completed NCT04717765 - Photobiomodulation in Oral Lesions Resulting From Anti-neoplastic Prevention N/A

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