NCT03491176

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
May 2017Oct 2027

Study Start

First participant enrolled

May 18, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 9, 2018

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

10.5 years

First QC Date

March 23, 2018

Last Update Submit

November 7, 2025

Conditions

Cutaneous Squamous Cell Carcinoma of the Head and NeckHealthy SubjectHead and Neck Cancer

Keywords

Head and Neck CancerMagnetic resonance imagingMRIBiomarker testingBlood drawsQuestionnairesSurveys

Outcome Measures

Primary Outcomes (3)

  • Tumor growth velocity (TGV)

    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

    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)

    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 Outcomes (1)

  • Locoregional control

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

Study Arms (1)

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.

Procedure: Biospecimen CollectionProcedure: Magnetic Resonance ImagingOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Biospecimen CollectionPROCEDURE

Undergo collection of blood samples

Diagnostic (MRI, blood sample collection)
Magnetic Resonance ImagingPROCEDURE

Undergo MRI scan

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Diagnostic (MRI, blood sample collection)
Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
Diagnostic (MRI, blood sample collection)
Questionnaire AdministrationOTHER

Ancillary studies

Diagnostic (MRI, blood sample collection)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MD Anderson Cancer Center

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Ng SP, Bahig H, Wang J, Cardenas CE, Lucci A, Hall CS, Meas S, Sarli VN, Yuan Y, Urbauer DL, Ding Y, Ikner S, Dinh V, Elgohari BA, Johnson JM, Skinner HD, Gunn GB, Garden AS, Phan J, Rosenthal DI, Morrison WH, Frank SJ, Hutcheson KA, Mohamed ASR, Lai SY, Ferrarotto R, MacManus MP, Fuller CD. Predicting treatment Response based on Dual assessment of magnetic resonance Imaging kinetics and Circulating Tumor cells in patients with Head and Neck cancer (PREDICT-HN): matching 'liquid biopsy' and quantitative tumor modeling. BMC Cancer. 2018 Sep 19;18(1):903. doi: 10.1186/s12885-018-4808-5.

    PMID: 30231854DERIVED

Related Links

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Clifton D Fuller

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2018

First Posted

April 9, 2018

Study Start

May 18, 2017

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

November 10, 2025

Record last verified: 2025-11

Locations

US(1)