Houston, Texas 77030


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Biopsy proven diagnosis of squamous cell carcinoma (SCC) of head and neck mucosa. Clinical evidence should be documented, and may consist of imaging, endoscopic evaluation, palpation, and should be sufficient to estimate the size of the primary for purposes of T staging - No distant metastases, based on routine staging workup - Consent for blood collection for biomarker analysis - No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies - Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2 - Dispositioned to curative intent radiotherapy - For females of child-bearing age, a negative pregnancy test Exclusion Criteria: - Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity) - Pregnant or breast-feeding females - Contraindications to magnetic resonance (MR) imaging (e.g. implanted metallic prostheses, defibrillators, or stimulators) - History of claustrophobia - Contraindications to gadolinium contrast (e.g. kidney dysfunction)


NCT ID:

NCT03491176


Primary Contact:

Principal Investigator
Clifton D Fuller
M.D. Anderson Cancer Center

Clifton Fuller, MD, PHD
Phone: 713-563-2300
Email: cdfuller@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Clifton D. Fuller
Phone: 713-563-2300

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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