NCT03491176

Magnetic Resonance (MR) Imaging & Blood Biomarkers for Head and Neck Cancer

Quantification of Tumor Imaging Kinetics and Blood Biomarkers in Head and Neck Cancer Patients

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this research study is to find out if using additional MRIs and biomarker testing can help researchers learn to predict how the tumor may change during radiation therapy. Biomarkers are found in the blood/tissue and may be related to participant's reaction to treatment. Biomarker testing in the study may include genetic biomarkers. This is an investigational study. MRIs on this study are performed using FDA-approved and commercially available methods. Having added scans and blood tests is investigational. Up to 100 participants will be enrolled in this study (up to 80 patients and up to 20 healthy volunteers in another part of the study). All will take part at MD Anderson.

Detailed description

PRIMARY OBJECTIVES: I. To assess the prognostic value of pretreatment volumetric tumor growth velocity (TGV), weekly tumor kinetics (TK), and blood biomarkers of mucosal head and neck cancers during radiation therapy (RT), using magnetic resonance imaging (MRI). SECONDARY OBJECTIVES: I. To assess functional imaging kinetics as a marker of tumor locoregional control. II. To correlate blood biomarkers with tumor kinetics during treatment. III. To generate preliminary data for future trials. OUTLINE: Patients undergo MRI scans and collection of blood samples for biomarker testing pre-radiation therapy, weekly during radiation therapy, and at 2-3 months post-radiation therapy. After completion of study, patients are followed up weekly.

Conditions

• Cutaneous Squamous Cell Carcinoma of the Head and Neck
• Healthy Subject
• Head and Neck Cancer

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI scan
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2017-05-18
• Primary completion: 2027-10-31
• Completion: 2027-10-31
• First posted: 2018-04-09
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States