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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491176
Recruitment Status : Recruiting
First Posted : April 9, 2018
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.


Condition or disease Intervention/treatment Phase
Cutaneous Squamous Cell Carcinoma of the Head and Neck Healthy Subject Head and Neck Cancer Procedure: Biospecimen Collection Procedure: Magnetic Resonance Imaging Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Quantification of Tumor Imaging Kinetics and Blood Biomarkers in Head and Neck Cancer Patients
Actual Study Start Date : May 18, 2017
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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 Collection
Undergo collection of blood samples

Procedure: Magnetic Resonance Imaging
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

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491176


Contacts
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Contact: Clifton Fuller, MD, PHD 713-563-2300 cdfuller@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clifton D. Fuller    713-563-2300      
Principal Investigator: Clifton D. Fuller         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Clifton D Fuller M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03491176    
Other Study ID Numbers: PA16-1041
NCI-2018-02631 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PA16-1041 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Cancer
Magnetic resonance imaging
MRI
Biomarker testing
Blood draws
Questionnaires
Surveys
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site