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

May 18, 2026 updated by: M.D. Anderson Cancer Center

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

MD Anderson Cancer Center

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diagnostic (MRI, blood sample collection)
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo collection of blood samples
Procedure: Magnetic Resonance Imaging
Undergo MRI scan
Other Names:
  • MRI
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and up to 2-3 months after completion of radiation therapy
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.
Baseline up to 2-3 months after radiation therapy
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.
Baseline and up to 2-3 months after completion radiation treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of first treatment to date of death, disease progression or recurrence, whichever occurs first, assessed up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Clifton D Fuller, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2017

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

March 23, 2018

First Submitted That Met QC Criteria

April 5, 2018

First Posted (Actual)

April 9, 2018

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA16-1041 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2018-02631 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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