Quantification of Tumor Imaging Kinetics and Blood Biomarkers in Head and Neck Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Tumor growth velocity (TGV)
Study Overview
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- Locoregional control(From date of first treatment to date of death, disease progression or recurrence, whichever occurs first, assessed up to 2 years)