Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03491176

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Cutaneous Squamous Cell Carcinoma of the Head and Neck Head and Neck Cancer Head and Neck Neoplasms Healthy Subject Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of blood samples

Magnetic Resonance Imaging

Procedure

Undergo MRI scan

Other names: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Tumor growth velocity (TGV)

    Time frame: Baseline and up to 2-3 months after completion of radiation therapy

    TGV is the calculated daily increase in tumor size from diagnosis to immediately before first radiotherapy (RT) treatment as measured via magnetic resonance imaging (MRI). Will use graphs and descriptive statistics to evaluate the relationship between TGV, tumor kinetics (TK), and circulating tumor cells (CTCs) with response.

  2. Change in TK

    Time frame: Baseline up to 2-3 months after radiation therapy

    Tumor kinetics is the weekly decrease or increase in tumor volume after initiation of radiotherapy, evaluated using MRI. Will also use generalized linear mixed models (GLMMs) to evaluate TK over time and to assess whether a difference exists between patients with complete response (CR) and those without CR. Will use graphs and descriptive statistics to evaluate the relationship between TGV, TK, and CTCs with response.

  3. Change in Blood Biomarkers of Mucosal Head and Neck Cancers During Radiation Therapy (RT)

    Time frame: Baseline and up to 2-3 months after completion radiation treatment.

    Will use GLMMs to evaluate CTCs over time and to assess whether a difference exists between patients with CR and those without CR. Will use graphs and descriptive statistics to evaluate the relationship between TGV, TK, and CTCs with response.

Secondary outcomes

  1. Locoregional control

    Time frame: From date of first treatment to date of death, disease progression or recurrence, whichever occurs first, assessed up to 2 years

    Locoregional control is defined as 2-year disease-free survival (DFS). Proportional hazards models will be created to examine the trajectory and intercept of TK and CTCs during radiation therapy with DFS. Time-varying covariates longitudinal modeling will be used to assess the relationship between TK and CTCs.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2018
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.