Magnetic Resonance (MR) Imaging & Blood Biomarkers for Head and Neck Cancer
NCT ID: NCT03491176
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
100 participants
OBSERVATIONAL
2017-05-18
2027-10-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Biospecimen Collection
Undergo collection of blood samples
Magnetic Resonance Imaging
Undergo MRI scan
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Biospecimen Collection
Undergo collection of blood samples
Magnetic Resonance Imaging
Undergo MRI scan
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Clifton D Fuller
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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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.
Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2018-02631
Identifier Type: REGISTRY
Identifier Source: secondary_id
PA16-1041
Identifier Type: OTHER
Identifier Source: secondary_id
PA16-1041
Identifier Type: -
Identifier Source: org_study_id